directorate general for internal policies - european parliament

DIRECTORATE GENERAL FOR INTERNAL POLICIES

POLICY DEPARTMENT A: ECONOMIC AND SCIENTIFIC POLICY

Workshop ‘Alternative Medicines’ Brussels - 30 November 2011

Proceedings

Abstract This is a summary of the presentations and discussions at a Workshop on Alternative Medicines held at the European Parliament. The workshop was organised with the aim of raising awareness about alternative medicines and exchanging views on the current legal framework. Seven experts covered topics such as Traditional Chinese Medicine, Ayurveda, Homeopathy, dietary methods and fasting, and others. A representative of the European Commission contributed comments about the present regulatory scenario.

IP/A/ENVI/WS/2011-10 December 2011 PE 475.079 EN

This workshop was requested by the European Parliament's Committee on Environment, Public Health and Food Safety CONTRIBUTING EXPERTS Dr Yu Han, Traditional Chinese Medicine (China/UK) Dr Harsha Gramminger, Ayurvedic Mediicine (Germany) Dr Ton Nicolai, Homeopathy in Europe (The Netherlands) Dr Andreas Buchinger , The remedial Fasting (Germany) Dr Natasha Campbell-McBride, Nutritherapy for brain problems (Russia/UK) Dr Aleksandar Mitov, Thermoregulation methods (Macedonia) Dr Elio Rossi, complementary and alternative medicine for cancer (Italy) Dr Andrzej Rys, Director , DG SANCO RESPONSIBLE ADMINISTRATOR Dr Marcelo SOSA IUDICISSA Dr Purificación TEJEDOR DEL REAL Policy Department Economic and Scientific Policy European Parliament B-1047 Brussels E-mail: [email protected] SUMMARY PREPARED by:

Mr Tony Zamparutti Ms Katalin Császár Mr Gavin McBride Milieu Ltd. Brussels, Belgium ABOUT THE EDITOR

To contact the Policy Department or to subscribe to its monthly newsletter please write to: [email protected]

Manuscript completed in December 2011 Brussels, © European Union, 2011

This document is available on the Internet at: http://www.europarl.europa.eu/activities/committees/studies.do?language=EN LINGUISTIC VERSION Original: EN DISCLAIMER The opinions expressed in this document are the sole responsibility of the author(s) and do not necessarily represent the official position of the European Parliament.

Reproduction and translation for non-commercial purposes are authorised, provided the source is acknowledged and the publisher is given prior notice and sent a copy.

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Workshop on ‘Alternative Medicines’/Workshop Proceedings ____________________________________________________________________________________________

CONTENTS

LIST OF ABBREVIATIONS 4

EXECUTIVE SUMMARY 5

1. LEGAL AND POLICY BACKGROUND 7

2. PROCEEDINGS OF THE WORKSHOP 10 2.1. PART 1: DISTINGUISHED EXPERTS 10

2.1.1. Welcome and opening – MEP Alojz PETERLE substitute on the Committee on the Environment, Public Health and Food Safety, Co-chair of the Working Group on Health of the ENVI Committee 10 2.1.2. Dr. Yu HAN, Traditional Chinese Medicines Practitioner, General Secretary of the UK Association of Traditional Chinese Medicines 10 2.1.3. Dr. Harsha GRAMMINGER, Ayurveda Practitioner, President of the European Ayurveda Association 11 2.1.4. Dr. Ton NICOLAI, Homeopathy Practitioner, President of the European Committee for Homeopathy 11 2.1.5. Dr. Andreas BUCHINGER, Medical Practitioner and Director of the Dr. Otto Buchinger Clinic 12 2.1.6. First round of Questions and Answers 13 2.1.7. Dr. Natasha CAMPBELL-MCBRIDE, Physician-Neurologist and Nutri-therapist 14 2.1.8. Dr. Aleksandar MITOV, Health Specialist and Medical Doctor 15 2.1.9. Dr Elio ROSSI, Medical Doctor/Director of a Homeopathy Clinic 16 2.1.10. Second round of Questions & Answers 17

2.2. PART 2: COMMENTS 19 Dr Andrzej RYS, Director of the Health Systems and Products Directorate of DG SANCO 19

2.3. PART 3: DISCUSSION 21 2.4. CONCLUSIONS: MEP ALOJZ PETERLE 22

ANNEX I: WORKSHOP PROGRAMME 23

ANNEX II: SHORT BIOGRAPHIES OF EXPERTS 24

ANNEX III: PRESENTATIONS 28

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Policy Department A: Economic and Scientific Policy ____________________________________________________________________________________________

LIST OF ABBREVIATIONS

CAM Complementary and Alternative Medicine

DG SANCO Directorate General for Health and Consumers

ENVI Environment, Public Health and Food Safety Committee

EPAAC European Partnership for Action Against Cancer

EU European Union

FP7 Seventh Framework Programme

MEP Member of the European Parliament

OECD Organisation for Economic Co-operation and Development

TCM Traditional Chinese Medicine

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EXECUTIVE SUMMARY Background The ‘Alternative Medicines’ workshop was organised by the Policy Department A-Economy & Science following the request of the Committee on Environment, Public Health and Food Safety (ENVI) of the European Parliament (30 November 2011), and was hosted by Mr PETERLE, who is co-chair of the ENVI Committee’s Working Group on Health. The workshop was structured in two panels, the first part dedicated to the presentation of alternative therapies and methods, and a second part focusing on the harmonisation measures in that area. Aim The workshop was organised with the aim of raising awareness about alternative medicines and exchanging views on the current legal framework. In opening the workshop, Mr PETERLE pointed out that many European citizens use alternative medicines. He underlined, however, that the regulatory status of Alternative Medicine practices and products varies across Member States. He expressed his hope that the workshop ‘could lead to the normalisation of the status of Alternative Medicines and also to [their] demystification’. Mr PETERLE also said that Alternative Medicines can be effective, for example, in the prevention of disease, as well as being cost-effective. The workshop panel consisted of seven practitioners in the field of alternative therapies and medicines, and each provided a short presentation on their particular area of practice, Dr. Yu HAN, the General Secretary of the UK Association of Traditional Chinese Medicines (TCM) gave an overview of TCM and said that ‘TCM is a safe therapy when carried out by a well-qualified practitioner’. Dr. Harsha GRAMMINGER, the President of the European Ayurveda Association, provided insight into the most commonly used ayurvedic therapies and explained their health benefits. She emphasized that ‘Ayurveda could have huge financial and social benefits for the Member States’ health care systems’. Dr. Ton NICOLAI, President of the European Committee for Homeopathy, highlighted the increasing number of EU citizens using this therapy. Dr NICOLAI also said that the current EU and national legal framework for alternative practices and medicinal products is unsatisfactory. Dr. Andreas BUCHINGER of the Dr. Otto Buchinger Clinic described the health benefits of remedial fasting. He explained that fasting is a powerful tool to help patients with chronic diseases and emphasized that fasting is a cost-effective and sustainable way to treat patients. Dr. Natasha CAMPBELL-MCBRIDE, a physician and nutri-therapist, described nutritional therapy as a powerful therapy for treating brain dysfunctions.

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Policy Department A: Economic and Scientific Policy ____________________________________________________________________________________________ Dr. Aleksandar MITOV, a health specialist from the Former Yugoslav Republic of Macedonia, emphasized the need for a ‘paradigm shift’ in Europe, moving away from reactive health care towards preventive approaches. He said that reactive health care is not sustainable, given its costs and Europe’s ageing population. He explained that alternative therapies (e.g. Thermo-regulation therapy) which are cost-effective, enhance the natural resilience of patients to diseases, and have measurable results, are effective tools in the prevention of disease. Dr. Elio ROSSI, representing the Tuscany Region Network for Integrative Medicine, described current research on the role of complementary and alternative medicines (CAM) in cancer treatment. Despite the benefits of such therapies, Dr. ROSSI emphasized that ‘CAM therapies should never be used as a replacement of conventional cancer care’, and he called for further research on this topic. During the second part of the workshop, Dr. Andrzej RYS, the Director of the Health Systems and Products Directorate of DG SANCO, confirmed that the number of European patients using alternative medicines is increasing. Dr. RYS gave an overview of the current EU legal framework affecting alternative medicine practices and medicinal products. Although many speakers of the workshop referred to the shortcomings of the Herbal Medicines Directive (Directive 2004/27/EC), Dr. RYS said ‘it is too early to say how the Directive is working’, as it has only recently become fully operational, and a revision is not being considered at this stage. He said that the European Commission will continue to follow the field of alternative medicines and to support research in this area. In his closing remarks, Mr PETERLE stressed that the European Parliament will continue to pay attention to CAM products and therapies. Mr PETERLE also said that the European Parliament would prepare an own initiative report to raise awareness about alternative medicines in the EU.

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1. LEGAL AND POLICY BACKGROUND An increasing number of European citizens use alternative medicines. According to a joint report of main European and international complementary and alternative medicine (CAM) associations,1 about 65% of Europe’s population has already used CAM. The Report states that ‘Approximately 30-50% of the European population uses CAM as self-support and 10-20% of the European population has seen CAM physician/practitioners within the previous year [2009]’. The number of CAM-trained practitioners is also growing in the EU, with an estimated figure of around 180,000 doctors. The growing use of CAM among European citizens and practitioners constitutes a regulatory challenge for the European Union. Among the key challenges are the different regulatory status of CAM practices and products in the Member States as well as the fact that some of the health related topics fall within the exclusive competence of the Member States. As an example of the different regulatory status of CAM, it is worth mentioning that in some countries alternative therapies are provided outside conventional health care institutions, whereas in others they are provided as part of conventional health care services. Another element is that in some Member States, CAM can only be provided by medical practitioners, whereas in others, non-medical practitioners may also provide certain alternative therapies. Moreover, there is no mutual recognition of CAM diplomas among the Member States, which hinders the free movement of CAM practitioners. In order to overcome these differences, the European Union has already carried out the first steps towards EU-wide harmonisation. The first legal instrument regulating CAM products was adopted in 1992 (Directive 92/73/EEC),2 which was repealed in 2001 by the so-called “[Homeopathic] Medicinal Products Directive”.3 This Directive together with the Herbal Medicine Directive,4 aim to provide patients with a sufficient level of information so as to ensure the safety and good quality of traditional medicinal products on the market. To this end, the Directives have introduced special authorisation and registration procedures for CAM products. Some practitioners argue that the legal framework for herbal medicinal products is not adequately tailored to the characteristics of these products. As Dr. RYS noted in his presentation, the Herbal Medicine Directive has only recently become fully operational after a seven year transitional period given for its implementation. Thus, the European Commission is not considering the revision of the Directive at this stage.

1http://www.homeopathyeurope.org. 2 Council Directive 92/73/EEC of 22 September 1992 widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down additional provisions on homeopathic medicinal products, OJ L 297, 13.10.1992, p. 8–11. 3 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p. 67–128. 4 Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 136, 30.4.2004, p. 85–90.

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The Professional Qualifications Directive1 which regulates the cross-border recognition of many professions in Europe, was adopted in 2005. This Directive, however, does not foresee the automatic recognition of CAM qualifications. The Directive is under revision and is currently subject to inter-service consultation. In 2011, the European Union also adopted the so-called Cross-border Health Directive,2 which focuses on the safe and good quality of treatments across borders. The Directive provides that patients are allowed to receive health care in another Member State and be reimbursed up to the level of costs that would have been assumed by the Member State of affiliation, if this health care had been provided in their own Member State. Moreover, the Directive also ensures that patients receive a sufficient level of information about cross-border health services. In the context of CAM products, the Regulation on Nutrition and Food Claims3 is also noteworthy. This Regulation is important, particularly as the distinction between food supplements and herbal medicines is not always clear. As the report of the European Information Centre for Complementary and Alternative Medicine suggests,4 sufficient levels of scientific data on the possible risks and benefits of CAM could facilitate the development of a suitable regulation for CAM products and practices. To this end, the EU has provided funding opportunities to CAM research programmes. As an example, the CAMbrella project could be mentioned, which was established under the Seventh Framework Programme (FP7) in January 2010, with the aim of ‘developing a roadmap for future CAM research that is appropriate for the health care needs of European citizens and acceptable to the European Parliament as well as national research funders and health care providers.’5 Complementary and alternative therapies with their holistic and integrative approaches are considered to be effective methods of prevention. One of the core objectives of the European Union’s Health Strategy is to focus more on prevention.6 According to the EU Health Strategy ‘health care spending should be accompanied by investment in prevention, protecting and improving the population’s overall psychical and mental health which, according to OECD data currently amounts to an average of 3% of the Member States’ total budget for health compared to 97% spent on health care and treatment’. The necessity of a paradigm shift towards preventive healthcare in Europe is reflected in many journals7 and policy documents of the European Union.8 This paradigm shift is necessary in order to overcome a number of difficulties faced by Europe’s health care. This idea is also reflected in the EU Healthcare Strategy which acknowledges that ‘EU health systems are under mounting pressure [...]’ and that there is a need to ‘shift from hospital care to prevention and primary care.’1

1 Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications, OJ L 255, 30.9.2005, p. 22–142. 2 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border health care, OJ L 88, 4.4.2011, p. 45–65. 3 Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. 4 Source: http://www.eiccam.eu/pdfs/eiccambrochurecomplete.pdf. 5 Source: www.cambrella.eu/home.php. 6 Together for Health: A strategic approach for the EU 2008-2013. Source: ec.europa.eu/health-eu.doc/whitepaper_en.pdf. 7 Source: ‘The future of healthcare in Europe- A report from the Economist Intelligence Unit’ http://www.eufutureofhealthcare.com. 8 Source: Transforming the European healthcare landscape http://ec.europa.eu/information_society/activities/health/docs/publications/ictforhealth-and-i2010-final.pdf.

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http://ec.europa.eu/information_society/activities/health/docs/publications/ictforhealth-and-i2010-final.pdf


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The pressure towards this shift is compounded by the challenge of the ageing population of Europe. This constitutes a two-fold problem for Europe’s health care, namely the changing disease patterns (i.e. chronic diseases) and increasing costs for reactive health care. These challenges can be addressed inter alia by the promotion of preventive methods and therapies. Professional CAM associations, such as the European Federation for Complementary and Alternative Medicine,2 argue that CAM methods may provide cost-effective solutions to these problems as they may cure patients with chronic diseases, contribute to the prevention of diseases and thus provide solutions for some of the health problems of Europe’s ageing population. The potential health and financial benefits of CAM methods have also been recognised by the European Parliament. In its 1997 resolution,3 the European Parliament acknowledged the preventive role of non-conventional medicines, and called on the European Commission to assess the safety and effectiveness of such medicines. In 2010, the CAM Interest Group was founded, which is an informal group of members of the European Parliament with a special interest in Complementary and Alternative Medicine. This Interest Group aims to put and keep CAM on the EU policy agenda, generate discussions and actions in that area, as well as to promote awareness about CAM and other holistic approaches. This workshop organised by the Committee on Environment, Public Health and Food Safety on ‘Alternative Medicine’ also served to highlight the increasing interest in complementary and alternative medicines in the EU. As Mr PETERLE mentioned in his concluding remarks, the European Parliament will continue to follow the policy and legal developments in this area. He also said that the least the European Parliament can do is to prepare an own-initiative report on the CAM situation in Europe in order to show the European Commission where the gaps are and what could possibly be done.

1 Together for Health: A strategic approach for the EU 2008-2013. Source: ec.europa.eu/health-eu.doc/whitepaper_en.pdf 2Source: http://ec.europa.eu/research/horizon2020/pdf/contributions/post/european_organisations/european_federation_for_complementary_and_alternative_medicine_-_efcam.pdf. 3Source: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+REPORT+A4-1997-0075+0+DOC+XML+V0//EN#Contentd683195e374.


2. PROCEEDINGS OF THE WORKSHOP 2.1. PART 1: DISTINGUISHED EXPERTS 2.1.1. Welcome and opening – MEP Alojz PETERLE substitute on the Committee on the Environment, Public Health and Food Safety, Co-chair of the Working Group on Health of the ENVI Committee In opening the workshop, Mr PETERLE pointed out that many European citizens use alternative medicines and thus this topic is close to them. He underlined, however, that the regulatory status of Alternative Medicine practices and products varies across Member States. In many Member States alternative medicines do not have the same regulatory status as conventional medicines. This means that alternative therapies are often provided outside the institutions where conventional health care is provided. In other Member States, such as in Slovenia, medical practitioners are even forbidden to provide alternative therapies. He expressed his hope that the workshop ‘could lead to the normalisation of the status of Alternative Medicines and also to [their] demystification’. Mr PETERLE also said that the recognition and provision of alternative and complementary practices and medicines could also lead to the pluralisation of treatments. 2.1.2. Dr. Yu HAN, Traditional Chinese Medicines Practitioner, General Secretary of the UK Association of Traditional Chinese Medicines Dr. Yu HAN explained that ‘Traditional Chinese Medicine (TCM) is a traditional Chinese medical system with a holistic approach to the diagnosis, prevention and treatment of diseases by identifying disease patterns and using individual or combined traditional therapies, such as acupuncture or Chinese herbal medicine.’ Over one third of the world’s population uses TCM as a health care service to preserve the well-being of their body and mind as well as to prevent and cure disease. TCM is based on a tradition which is more than 3000 years old. Dr. HAN described the views behind TCM, such as the yin-yang universal opposites, which influences the understanding that a body is healthy if the two elements (yin-yang) are in balance; and the understanding that all phenomena of living world manifest through five elements-qualities - represented by wood, fire, earth, metal and water. These basic materials are used by practitioners to explain the physiology and the pathology of the disease. Dr. HAN explained that TCM focuses on the functions of the body rather than its anatomical structure, aiming at restoring equilibrium. Dr. HAN also provided an insight into the major therapies of TCM, which are acupuncture, Chinese herbal medicine, tui na massage, cupping therapy, dietary therapy and qi gong. She emphasized that ‘TCM is a safe therapy when carried out by a well-qualified practitioner’. Finally, Dr. HAN gave an overview of the TCM developments in China. She said that in China, TCM and western medicine are equally important. In 2006, over 90% of the Chinese clinics had TCM departments and more than 524,000 licensed physicians were also trained TCM doctors. She said that TCM is also popular in Europe, and in the UK alone there are over 2500 TCM practitioners and 4000 acupuncturists. Dr. Han’s presentation on ‘Traditional Chinese Medicines’ can be found in Annex II.

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2.1.3. Dr. Harsha GRAMMINGER, Ayurveda Practitioner, President of the European Ayurveda Association Dr. GRAMMINGER explained that Ayurveda is a 5000 year old medical tradition, which originated in India. Ayurveda is a preventive and curative medicine, which is used by over a quarter of the world’s population. This herbal and holistic medicine has eight branches, which include inter alia inner medicine, psychology and reproductive health and toxicology. She described that Ayurveda operates with the balancing of three elemental energies: vata (air and space), pitta (fire and water) and kapha (water and earth). According to ayurvedic medical theory, if these three elements exist in equal quantities, the body will be healthy. Dr. GRAMMINGER introduced the main ayurvedic therapies, which are diet and lifestyle advice, medicines, oil massage, heat treatments, detoxification therapy, yoga and meditation. Dr. GRAMMINGER emphasized that ‘Ayurveda works on a scientifically measurable physiological and psychological level, thus is not a ‘quackery’’. She also said that Ayurveda is not a ‘one hat fits all’ system, but always provides the basis for an individualised treatment to patients. Dr. GRAMMINGER highlighted the health benefits of Ayurveda as a powerful treatment to cure chronic diseases, such as diabetes, hypercholesterolemia or rheumatic diseases. She also emphasized that ‘Ayurveda would have huge financial and social benefits for the Member States’ health care systems’, since patients of ayurvedic treatments can avoid long term drug dependencies and complex medical interventions. As a result, the costs of treatments could be significantly cut. She also mentioned the benefits of Ayurveda for the EU’s ageing population, which is relevant to the EU’s priority of ensuring the healthy and active ageing of all citizens. Dr. GRAMMINGER expressed her hopes for further EU funding in order to research and better demonstrate the health benefits and effectiveness of Ayurveda. She also expressed concern about the fact that in most Member States health insurance systems do not cover alternative therapies and medicines. Moreover, she emphasized the need for information centres, where patients can get more information about alternative medicine. Dr. GRAMMINGER also referred to the increasing interest of EU citizens in maintaining their mental and physical health. To this end, she recommended increased integration of information on healthy lifestyle and health education as well as investing more in the training and education of doctors involved in ayurvedic medicine. Dr. GRAMMINGER also said that ‘Alternative medicines should be integrated into the conventional health care system’. Dr. GRAMMINGER’s presentation on ‘Ayurvedic Medicine’ can be found in Annex II. 2.1.4. Dr. Ton NICOLAI, Homeopathy Practitioner, President of the European Committee for Homeopathy

Dr. NICOLAI emphasized the growing demand for homeopathy from both doctors and patients. He said that ‘three out of four EU citizens know about homeopathy, of these 29% use it for their health care’. These figures suggest that over 100 million EU citizens use homeopathy regularly. Dr. NICOLAI described homeopathy as a long-standing European therapeutic tradition, which is considered as a gentle, safe and effective therapy. Homeopathy is based on the similarity principle, which implies that substances capable of causing disorder in healthy subjects are used as medicines to treat similar patterns of disorder experienced by ill people.

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Other principles of homeopathy include the individualization of treatment for patients and the use of minimum doses. Dr. NICOLAI explained the main reasons why doctors and patients turn towards homeopathy. For example, many citizens use homeopathy to ‘avoid long-term or even life-long dependency on conventional prescribed drugs’ and doctors tend to use homeopathy because they find it highly effective. Dr. NICOLAI noted that there are over 50,000 trained homeopathy doctors in Europe and many hospitals for example in the United Kingdom or Germany providing homeopathic treatment in their out-patient care. Universities often offer courses on homeopathy in their medical undergraduate and postgraduate educational programmes. He also said that compared to conventional therapies, homeopathy offers a ‘safe and cost-effective treatment’. Dr. NICOLAI explained that the regulatory status of complementary and alternative medicines (CAM) and practices varies across the EU. One problem is that medical practitioners in some Member States are not allowed to provide CAM therapies. He also noted that there is no mutual recognition of CAM qualifications between the EU Member States, which impedes the free movement of CAM practitioners. He expressed his wish to extend the scope of Directive 2005/36/EC1 on the recognition of professional qualifications to CAM practitioners. With regard to homeopathic medicines, Dr. NICOLAI referred to the Commission Communication from 20082 which stated that ‘Directive 2004/24/EC3 is not appropriate for a global regulation of such medical practices [anthroposophic, ayurvedic and TCM]’. He expressed his hope for a separate legal framework for products of certain traditions and addressed the European Parliament to initiate the adoption of a new legal instrument. Finally, Dr. NICOLAI mentioned the existence of EUROCAM, which is a multi-stakeholder group of physicians, practitioners and patients in the field of CAM. He said that EUROCAM works closely with the European Parliament’s CAM Interest Group and is engaged in on-going dialogues with the European Commission. Moreover, with the support of DG SANCO, EUROCAM is organising a full-day conference on CAM for Public Health in 2012. Dr. NICOLAI’s presentation on ‘Homeopathy’ can be found in Annex II. 2.1.5. Dr. Andreas BUCHINGER, Medical Practitioner and Director of the Dr. Otto Buchinger Clinic Dr. BUCHINGER described remedial fasting as ‘the conscious voluntary renunciation of solid food for a limited period of time.’ He emphasized that fasting is not a ‘zero-calorie diet’, but a low-calorie drinking diet, which protects the vital structures of the body. Dr. BUCHINGER explained that fasting is not only a preventive and/or curative therapy, but it also provides the patients with ideas about a healthy lifestyle and introduces them to the ‘world’ of healthy food.

1 Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications, OJ L 255, 30.9.2005, p. 22–142. 2 European Commission Communication COM(2008)584 on experience acquired as a result of the application of Directive 2004/24/EC’s provisions. 3 Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 136, 30.4.2004, p. 85–90.

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He explained that there are various kinds of fasting, such as therapeutic fasting (i.e. fasting therapy or remedial fasting) and preventive fasting. Both may have health benefits for patients with chronic and epidemic diseases, such as allergy, type-2 diabetes, high blood pressure, cardio-vascular disorders, arthritis and chronic inflammatory bowel disease. In Germany, fasting can be provided as an in-patient care in specialised clinics or as an out-patient therapy, in which case the medically managed fasting is prescribed by practicing physicians. Fasting also exists for healthy people, who need to provide proof from their doctors about their healthy conditions. However, Dr. BUCHINGER emphasized that fasting is not recommended for those who suffer from advanced liver and renal failure, eating disorders, or are pregnant. Dr. BUCHINGER explained that at the beginning of each fasting, it is obligatory to check the patient’s health, requiring several tests, e.g. a blood test, blood-pressure and electrocardiogram tests and sleep-apnea screening. Each fasting therapy starts with a transitional period, when patients eat only vegetables and fruit meals. During these first few days, patients are withdrawn from stimulants such as coffee or cigarettes and are encouraged to rest and relax. The main phase of remedial fasting is liquid-based therapy, during which patients take only fluids. In order to prevent discomfort, patients are given sodium sulphate or other salts. During the ‘post-fasting days’, patients are re-introduced to solid food components and are taught about healthy eating habits. Dr. BUCHINGER said that the positive results of fasting are tremendous, e.g. decreasing lipid levels, blood sugar levels, liver enzymes and blood pressure. Dr. BUCHINGER emphasized that remedial fasting provides a sustainable and cost-effective solution for patients. Moreover, he mentioned that due to its acknowledged health benefits, fasting is subject to more and more world-wide research programmes and studies. Recent research has involved looking into the benefits of fasting in the treatment of cancer. Dr. BUCHINGER’s presentation on ‘Remedial Fasting’ can be found in Annex II. 2.1.6. First round of Questions and Answers After the first part of the workshop, Mr PETERLE opened the floor for questions and said that he was pleased to hear about the scientifically proven benefits of complementary and holistic approaches, noting that the results of such therapies are measurable. Mr PETERLE was also delighted to hear presentations emphasizing the benefits of preventive methods and presentations about the financial and legal aspects of the use and practice of such methods. Moreover, Mr PETERLE said that these aspects are in line with the EU 2020 objectives.1 No questions were asked after the first part of the workshop.

1 Promoting good health is important objective of the Europe 2020 Strategy, and is referred to under the objectives of smart and inclusive growth. Source: http://ec.europa.eu/europe2020/index_en.htm.

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Policy Department A: Economic and Scientific Policy ____________________________________________________________________________________________ 2.1.7. Dr. Natasha CAMPBELL-MCBRIDE, Physician-Neurologist and Nutri-therapist In her opening, Dr. CAMPBELL-MCBRIDE said that from her perspective ‘nutritional therapy is the most powerful way of Alternative Medicines’. Nutri-therapy is based on the idea that there is a connection between the functions of the digestive system, the general health status of the person, and the brain. Dr. CAMPBELL-MCBRIDE said that Hypocrates originally acknowledged that ‘All diseases begin in the gut’. This statement has been confirmed by many physicians and scientists over the centuries, such as by Philippe Pinel in 1807. Modern clinical experience proves how correct these theories were and that there is a connection between the state of gut and the health of the brain. Dr. CAMPBELL-MCBRIDE explained that ‘90% of the cells in human body are gut flora (microbes)’. This number indicates that our health depends hugely on the health and status of this mixture of bacteria. A healthy gut flora with its healthy microbes ensures that food is properly digested and absorbed. She said that if the gut flora is not healthy (e.g. too much pathogenic and disease causing microbes, pathogenic fungi, bacteria and viruses and parasites), patients can suffer from brain disorders and other chronic diseases, such as cancer. She explained that ‘people with an unhealthy gut develop multiple nutritional diseases and their gut instead of being nourished becomes a major source of toxicity.’ The pathogenic microbes convert the food into toxins which, through the bloodstream, are distributed throughout the body. If these toxins reach the brain, they block the brain and it cannot function properly anymore, causing mental and physical problems. Many children and adults suffer from brain dysfunctions as a result, e.g. autism, dyslexia, dyspraxia, learning and behavioural problems and epilepsy for kids, and depression, eating disorders, maniac-depression, schizophrenia etc. In case of adults, these diseases often go hand-in-hand with substance abuse, alcohol and tobacco abuse and other addictive behaviours. Dr. CAMPBELL-MCBRIDE indicated the number of children suffering from autism. She said that 20 years ago there was only one child out of 10 000 thousand diagnosed with autism, whereas ‘today in the western world we are diagnosing one child out of 100.’ This is a one hundred-fold increase of newly diagnosed children with autism. She stressed that over 99% of these children are born with a perfectly normal brain, but in the first year they develop abnormal gut flora, which poisons their brains. Dr. CAMPBELL-MCBRIDE said that unfortunately, many physicians waste valuable time while trying to diagnose these children, 60-70% of whom do not fit into one single “diagnosis box”. Dr. CAMPBELL-MCBRIDE stressed that the longer physicians let patients suffer from the diseases the more difficult it is to treat them. Nutri-therapy focuses on the health of gut and applies diet as a treatment. Dr. CAMPBELL-MCBRIDE explained that this diet needs to be a specific diet, which heals and seals the gut. Other elements of the nutri-therapy are well-chosen nutritional supplements, the use of natural detoxification methods and life-style change. As a result of a nutri-therapy, the gut becomes a source of nourishment instead of a source of toxicity. In her closing remarks, Dr CAMPBELL-MCBRIDE presented her book called ‘Gut and Psychology Syndrome’ (2004), which aims to give a better understanding to the reader about the development of the syndrome and about how it can be treated effectively with a sound nutritional protocol.

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Dr. CAMPBELL-MCBRIDE’s presentation on ‘Nutri-therapy for brain problems’ can be found in Annex II. 2.1.8. Dr. Aleksandar MITOV, Health Specialist and Medical Doctor In the first part of his presentation, Dr. MITOV talked about medicine in general and explained the current paradigm within conventional medicine. The second part of his presentation focused on the method of thermoregulation as a therapy of ‘active prevention’. Dr. MITOV, first presented a graph prepared by the British Medical Journal of Clinical Evidence, which illustrates the effectiveness of conventional treatments. He said that out of 3000 treatments, only 11% are considered to be beneficial, whereas 51% of treatments have unknown effects. In this context he argued that conventional medicine needs a paradigm shift from reactive health care towards preventive approaches. He said that ‘reactive medicine is a burden for society, whereas preventive medicine could relieve it’. Dr. MITOV also stressed that while reactive medicines are costly, preventive ones are economically feasible. To support this, he noted that the total expenditure dedicated to prevention in the EU (including vaccines) is 2.8%, while 75% goes to the treatment of chronic diseases. Dr. MITOV highlighted two tendencies in Europe, namely the ageing population and the increasing rate of chronic diseases. He also pointed out the link between these two factors by saying that chronic diseases are more common among elderly. He explained that given these tendencies, conventional medicine is not a sustainable solution and stressed the well-known advantages of preventive solutions for chronic diseases. Dr. MITOV concluded the first part of the presentation by stating that ‘We need to focus on preventive medicine’. In the second part of his presentation, Dr. MITOV proposed four pivotal criteria in order to focus on prevention: scientific sustainability, enhancing the natural resilience of patients to diseases, measurability of results and cost-effectiveness. As an example of active prevention therapies, Dr. MITOV introduced the thermoregulation method, which is based on three pillars, namely on plant based nutrition, natural oils and non-invasive blood analysis. While explaining their unquestionable health benefits, Dr. MITOV argued that plant-based products are scientifically sustainable. Among others, he said that the advantages of plant-based nutrition to diseases have been highlighted by the CHINA study which ‘produced 8000 statistically significant associations’. In the context of plant based nutrition, Dr. MITOV also referred to evidence including a study by Newcastle University which indicated that type 2 diabetes was reversible by fasting. Dr. MITOV also highlighted the health benefits of natural cold pressed oils, which are easily absorbed by the human body and help it to gradually balance and heal itself. In order to illustrate that cold pressed oils enhance the resilience of patients, Dr. MITOV gave the example of Oil 57 (grape seed oil) which can inhibit human breast carcinoma, lung cancer and gastric cancer, and moreover can have anti-inflammatory, anti-bacterial, anti-viral and other beneficial effects on human disease conditions. He also emphasized that the health benefits of natural cold pressed oils have been scientifically proven.

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Policy Department A: Economic and Scientific Policy ____________________________________________________________________________________________ As regards measurability of results, Dr. MITOV noted that the AMP non-invasive blood analyser is an innovative piece of technology that applies sensors to five biologically active points on the human body surface and measures temperature, thereby determining the indicators of a comprehensive blood analysis which are used for diagnostics of diseases in medical practice. This analyser is able to provide 117 parameters within three minutes. In his concluding remarks Dr. MITOV emphasized that preventive methods are the most cost-effective means of addressing the problems faced by Europe’s health care system. Dr. MITOV’s presentation on ‘Reducing health care costs by increasing human natural resilience with ThermoRegulation Method’ can be found in Annex II. 2.1.9. Dr Elio ROSSI, Medical Doctor/Director of a Homeopathy Clinic Dr. ROSSI’s presentation focused on the use of CAM in cancer treatment, which is also known among practitioners as “Integrative oncology”. In his introduction, Dr. ROSSI mentioned that in Europe up to 35% of adults and 30-32% of child cancer patients use CAM. Dr. ROSSI described that CAM therapies are often used in addition to conventional treatments. These CAM therapies include the use of herbal medicines and supplements, Traditional Chinese Medicine, homeopathy, relaxation and spiritual therapies and the use of vitamins/minerals. The main stimuli for using alternative medicine, according to Dr. ROSSI were to maintain hope and the wish of patients to take an active role in their self-care. Dr. ROSSI emphasized that patients deciding to use CAM should always be informed about the potential risks and benefits of such therapies and medicines. Dr. ROSSI highlighted the potential negative consequences of using CAM therapies exclusively, by stating that ‘alternative therapies used as primary treatment for breast cancer can be associated with increased recurrence and death. Homeopathy, if used instead of surgery, results in disease progression in most patients’. In addition, Dr. ROSSI referred to the possible side effects of herbal medicines used by cancer patients and the fact that these medicines may interact with cancer drugs. By way of examples, Dr. ROSSI cited studies indicating that green tea may reduce the efficacy of bortezomib used for the treatment of myeloma, while hypericum reduces the efficacy of irinotecan used in the treatment of colon or rectal cancer. Dr. ROSSI noted that numerous research programmes and studies have been carried out in order to improve the limited information about the safety and effectiveness of CAM therapies in cancer treatment. For example, in 2009, the Society of Integrative Oncology issued clinical practice guidelines for doctors to consider when incorporating complementary therapies in the care of cancer patients. They have also highlighted key points for the safe use of CAM in cancer treatment, for example, that CAM therapies should never be used as a replacement for conventional cancer care or as a reason to postpone seeing a doctor about any problem and that before using CAM, cancer patients should consult with their doctors. As an example to research programmes, Dr. ROSSI introduced the CAM-CANCER project (Concerted Action for Complementary and Alternative Medicine Assessment in the Cancer Field) which is an EU project originally funded by the European Commission within the Fifth Framework Programme and is now hosted by the University of Tromsø in Norway.

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Dr. ROSSI explained that there are many centres, courses, universities and conferences focusing on the use of CAM therapies in cancer treatment. The First International Conference on Integrative Care for the Future was held in the Netherlands in March 2011. Dr. ROSSI explained that his region of Tuscany has also extensive experience in integrative oncology. There are over 100 centres in the region providing CAM therapies to patients, such as acupuncture, homeopathy and herbal medicines. Out of these 100 centres, five of them are considered as integrative oncology clinics. The Tuscany-model of integrative oncology is based on two pillars, physical activity and diet. As part of the physical activity, patients are treated with art therapy, such as dance or music and by psycho-oncology. In addition to this, the centres use other CAM therapies and narrative medicines. Centres in the Tuscany region are also engaged in collecting clinical evidence about the health benefits of using CAM therapies in cancer treatment. Dr. ROSSI also mentioned that the Tuscany Region Network for Integrative Medicines is an associated partner of the European Partnership for Action Against Cancer (EPAAC), which was launched in 2009 after the European Commission published its Communication on Action Against Cancer: European Partnership. The EPAAC consists of 38 associated partners, and has over 90 collaborating partners. The National Institute of Public Health in Slovenia is the leader of the EPAAC Joint Action. According to Work Package 7 of EPAAC, a specific objective of the Tuscany Region is to assess the evidence and use of CAM in cancer care and to assess the dissemination of CAM as well to review the evidence and map the EU’s CAM in cancer care. As part of its task, Tuscany Region is also circulating a survey to the cancer units of hospitals across the EU to identify clinical activities related to integrative medicine. Dr. ROSSI said that the results of these tasks will be presented in September 2012 in Florence, at the Fifth European Congress for Integrative Medicine. In his concluding remark Dr. ROSSI referred to a statement of a famous oncologist who said that ‘Integrative and complementary medicines can be a bridge between patients and doctors; it can be a balance point where cure is complemented by care and ambition is mitigated by empathy.’ 2.1.10. Second round of Questions & Answers After the presentations of the seven selected speakers, Mr PETERLE opened the floor for questions. Question 1 The first question was addressed to Dr. ROSSI. One attendee of the workshop asked about how the integrative centres are connected and how cancer patients can get in touch with such specialised health care centres. She also asked whether the integrative centres are in contact with conventional health care centres. This person also asked whether hospitals should meet certain criteria in order to join the network of integrative centres. Dr. ROSSI explained that setting up a network of integrative centres using CAM therapies in cancer treatment is the objective of the European Partnership for Action Against Cancer (EPAAC). Member organisations of this Partnership use similar therapies. Dr. ROSSI said that

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Policy Department A: Economic and Scientific Policy ____________________________________________________________________________________________ both private and public hospitals may join the network, in which patients are provided with the possibility of exercising their liberty of choosing among therapeutic approaches. Question 2 The second question was posed by Mr PETERLE and was addressed to Dr. BUCHINGER. Mr PETERLE asked about the estimated number of patients visiting the fasting clinic, and about the number of politicians making use of the therapies offered by the clinic. In his response, Dr. BUCHINGER explained that mostly businessmen and people from abroad visit his clinic. However, he also said that occasionally the clinic hosts politicians as well. In his reaction to Dr. BUCHINGER’s answer, Mr PETERLE asked about the percentage of those using fasting as a preventive measure and those using it as a curative therapy. Dr. BUCHINGER said that the number of patients using fasting as a preventive and curative therapy is equal. In addition, he pointed out that the number of patients suffering from metabolic diseases and type-2 diabetes increases every year. Dr. BUCHINGER said that fasting as a preventive therapy is more commonly used among younger patients. He explained that younger patients go to his clinic in order to learn more about healthy lifestyles. Dr. BUCHINGER also referred to the fact that patients are coming from all over the world to his fasting clinic, including the Middle East, Europe and the US. Moreover, Dr. BUCHINGER described that it is very important to be aware of the kinds of foodstuff available on the market. He said that based on his experience, there are many products in the supermarkets which are unhealthy and contain too much e-additives. Dr. BUCHINGER also stated that many people have unhealthy eating habits. As an example he referred to the fact that many people are eating five times per day. He said that the healthy way would be to limit the number of meals to three per day. Dr. BUCHINGER also mentioned that the shortest way to fast would be to skip the dinner, as this is the meal which is not necessary for the human body. Question 3 The third question was asked by Dr. CAMPBELL-MCBRIDE and was addressed to Mr PETERLE. Dr. CAMPBELL-MCBRIDE inquired whether the workshop would be followed by more meetings on CAM, and would lead to more progress in the area of CAM. In order to avoid misunderstanding, Mr PETERLE explained that this workshop is not the first to be organised on CAM-related topics, but ‘the first workshop organised in this set-up’. Mr PETERLE also noted that the future of CAM in Europe depends primarily on the developments of the legal framework. In this respect, the European Commission has more power, given that it is the institution having the power of taking legal initiatives. However, he said that the European Parliament has the means to stimulate the European Commission in taking certain steps. As an example, Mr PETERLE referred to the European Parliament’s self-initiative reports, and to its role in stimulating the decision-making process.

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Mr PETERLE also said that in his opinion the crisis of Europe’s health system will last longer than the current financial crisis. According to Mr PETERLE, the only way to solve the complex issues of Europe’s health care system would be to shift the paradigm. Mr PETERLE noted that only two years ago, when the hearings of the current commissioners took place, about six candidates referred to the ‘shift of paradigm’ in their speeches. Mr PETERLE said that this indicates how urgent the need for change is. As a final remark, Mr PETERLE said that the past has already shown that the European Parliament together with the European Commission and the Council can achieve positive results in the field of alternative medicine. As an example, he mentioned cancer therapies and explained that projects, programmes and partnerships in this area are relatively new and were introduced by the institutions following the request of the European Parliament. Moreover, Mr PETERLE emphasized that ‘health’ is still a key challenge for the European Union. 2.2. PART 2: COMMENTS Dr Andrzej RYS, Director of the Health Systems and Products Directorate of DG SANCO Dr. RYS first described the current status of alternative medicine in Europe. In this context he referred to the increasing number of European patients using alternative medicines and to the growing number of publications and scientific interests in this area. Dr. RYS also referred to the fact that ‘the variety, categorisation and definition of alternative medicines render regulation and professional challenges.’ As an example to professional challenges, he mentioned the problem of malpractice, and the different regulatory status of qualifications in the Member States. Dr. RYS emphasized that the European Commission is interested in this area. It regularly meets CAM organisations and supports CAM related research. As an example, he mentioned the CAMbrella project, which was established under the Seventh Framework Programme (FP7) in January 2010, with a total budget of EUR 1.5 million. He described that these ‘soft instruments’ are important tools to contribute to the development of Europe. In addition to the ‘soft tools’, Dr. RYS referred to the ‘hard tools’ used by the European Union. Dr. RYS associated these tools with legislative instruments, such as regulations and directives. In order to illustrate the complexity of the legislation on health, Dr. RYS explained that certain areas fall under the exclusive competence of Member States, whereas in some cases the EU and the Member States have shared competences. He also described that the EU legislation does not regulate CAM directly, but sets rules for the use and distribution of CAM products and the provision of CAM services. The first Directive which Dr. RYS mentioned was the Professional Qualifications Directive.1 Dr. RYS confirmed that the Directive is under revision, and is currently subject to inter-service consultation. He explained the significance of the Directive to the health care sector by saying that ‘according to DG MARKT, 46% of the professionals covered by the Directive are health professionals’.

1 Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications, OJ L 255, 30.9.2005, p. 22–142

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As a second Directive, Dr. RYS presented the recently adopted Cross-border Health Directive,1 which focuses on the safe and good quality of treatments across borders. The Directive provides that patients are allowed to receive health care in other Member States and be reimbursed up to the level of costs that would have been assumed by the Member State of affiliation, if this health care had been provided in their own Member State. As an important advantage of the Directive, Dr. RYS mentioned the provision and availability of sufficient level of information to patients. Dr. RYS also referred to the Medicinal Products Directive.2 He mentioned that in some countries, such as in Germany, Belgium or France, the use of homeopathic products and medicines have strong traditions, whereas in other countries these products and medicines are not commonly used. Dr. RYS mentioned that the main advantage of the Directive was the introduction of a market authorisation to homeopathic medicinal products. As a last element, with regard to homeopathic medicinal products, Dr. RYS mentioned that the approach of practitioners towards such products vary across Europe. Dr. RYS also referred to the revision of the Medicinal Products Directive by the Herbal Medicine Directive,3 which has recently become fully operational, after the transitional period passed. The main aim of the Directive is to provide patients with a sufficient level of information and to ensure the safety and good quality of traditional medicinal products on the market. To this end, the Directive introduced a special simplified registration procedure for herbal medicines, including TCM and Ayurveda products. Dr. RYS also described the important role played by the European Medicine Agency in the registration process. Although many speakers of the workshop referred to the shortcomings of the Herbal Medicines Directive, Dr. RYS said ‘it is too early to say how the Directive is working’, as it only recently has become fully operational, and a revision is not being considered at this stage. He said that the European Commission will continue to follow the field of Alternative Medicines and to support research in this area. As a last piece of relevant legislation, Dr. RYS referred to the Regulation on Nutrition and Food Claims4 from 2006. In the context of the implementation of this Regulation, Dr. RYS mentioned the important role played by the European Food Safety Agency. Dr. RYS explained that this Regulation is important, as the borderline between food supplements and herbal medicines is not always clear. In his concluding remark, Dr. RYS emphasized that prevention is a priority topic for the European Commission and is in the heart of the European Health Strategy. Dr. RYS said that the European Commission together with the OECD is working on a report which will collect evidence on the economic benefits of prevention. He mentioned that this study may convince finance ministers and other political leaders in the EU that the ‘shift of the paradigm’ is necessary. Dr. RYS referred to the EU’s efforts made with various stakeholders (e.g. NGOs, food industry, retailers) to reduce salt content in processed foods.

1 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border health care, OJ L 88, 4.4.2011, p. 45–65 2 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use 3 Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use 4 Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods

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2.3. PART 3: DISCUSSION Question 1 The first question was posed by Dr. NICOLAI and was addressed to Dr. RYS. Dr. NICOLAI asked whether the European Commission is planning to follow up on its statement made in its Communication (COM(2008)584). Dr. NICOLAI quoted the relevant paragraph of the Communication, which promised the revision of the Herbal Medicines Directive and the assessment of the suitability of a separate legal framework for alternative practices, such as Ayurveda or Traditional Chinese Medicine. Dr. RYS noted that at this stage the European Commission does not envisage a revision of the Directive. He explained that it is too early to see how the Directive is working and whether it hinders the placing on the market of traditional herbal medicines. Following Dr. RYS’s answer, Dr. GRAMMINGER claimed that given the current legislative framework which does not allow certain products to be registered as traditional herbal medicines, many practitioners in Europe are put in a situation in which they illegally use e.g. Ayurvedic and traditional Chinese products. In his response, Dr. RYS mentioned that products need to meet certain criteria to be registered. As an example, he mentioned that the products need to have been on the market for at least 15 years and used in Europe for at least 30 years. He emphasized that the European Commission together with herbal medicines associations constantly looks into possibilities to facilitate the registration of herbal medicines that meet the criteria referred to above. Question 2 Seamus CONNOLLY, the President of the European Federation for Complementary and Alternative Medicine, which represents almost 270000 non-medically trained practitioners in Europe, said that he fully agreed with Dr. NICOLAI and Dr. GRAMMINGER’s previous comments about the unsatisfactory legal framework. He said that according to many practitioners, the current Herbal Medicines Directive does not contribute to the safe access to herbal medicines. Mr CONNOLLY also mentioned that CAM practitioners are practising in a ‘grey legal area’. In order to ensure the safe and effective access to CAM medicines and modalities, Mr CONNOLLY said that the legal status of both practitioners and herbal medicines needs to be reassured and reconsidered. Finally, Mr CONNOLLY suggested to further discuss these issues in form of a separate meeting. In his response Dr. RYS listed the future occasions where these questions can be further discussed. In this context he mentioned a Conference next year and meetings of DG SANCO with CAM representatives in January. Question 3 Günter SCHULZ, the Head of Office of the International Federation of Anthroposophic Medical Associations, in Brussels, encouraged Mr PETERLE to organise similar events in the future, probably in collaboration with other interest groups of the European Parliament.

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Policy Department A: Economic and Scientific Policy ____________________________________________________________________________________________ Mr SCHULZ also argued that Members of the European Parliament should take the responsibility of preparing an own-initiative report on the CAM situation in Europe to support the general development and to show the European Commission where the gaps are and what could possibly be done. 2.4. CONCLUSIONS: MEP ALOJZ PETERLE In his concluding remarks, Mr PETERLE said that there are points with regard to the regulatory status of CAM practices and modalities which need to be further discussed. He said that despite the fact that regulating certain health-related areas fall within the competence of Member States, the European Union may play the role of stimulating certain harmonisation processes. As a problem, Mr PETERLE referred to the lack of knowledge about CAM practices and modalities in Europe. In this context, Mr PETERLE welcomed the recently adopted Cross-Border Health Directive, but emphasized the need for further comparative research. Mr PETERLE also said that ‘we should pay more attention to possibilities which offer more prevention in Europe.’ He argued that paying more attention to more natural, easily accessible and simple methods of health care would be beneficial to patients and would contribute to the prevention of diseases. Finally, Mr PETERLE addressed Mr SCHULZ’s question, by saying that ‘an own initiative report is the least the European Parliament can do’. MEP PETERLE thanked all of the speakers for the interesting discussion.

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ANNEX I: WORKSHOP PROGRAMME Policy Department A-Economy & Science

for the Committee on the Environment, Public Health and Food Safety (ENVI)

Working Group Health

Workshop

'ALTERNATIVE MEDICINES' Wednesday, 30 November 2011

16.30 - 18.30 hrs European Parliament, Brussels Room Altiero Spinelli, A 5-G-2

AGENDA

16.30 Welcome and Opening by Glenis WILLMOTT (excused) and Alojz PETERLE,

MEPs, Co-chairs of the Working Group on Health of the ENVI Committee 16.35 Traditional Chinese Medicine Dr Yu Han (China/United Kingdom) 16.45 Ayurvedic Medicine Dr Harsha Gramminger (Germany) 16.55 Homeopathy in Europe Dr Ton Nicolai (The Netherlands) 17.05 The Remedial Fasting Dr Andreas Buchinger (Germany). 17.15 First round of Questions & Answers 17.25 Nutritherapy for brain problems Dr Natasha Campbell-McBride (Russia/UK) 17.35 Thermoregulation methods for optimal health Dr Aleksandar Mitov (Former Yugoslav Republic of Macedonia) 17.45 Complementary and Alternative Medicine for Cancer Dr Elio Rossi (Italy) 17.55 Second round of Questions & Answers 18.05 Comments

Dr Andrzej Rys, Director Health Systems & Products, European Commission DG SANCO

18.15 Discussion 18.25 Closing remarks by the Chair 18.30 End of meeting

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ANNEX II: SHORT BIOGRAPHIES OF EXPERTS Dr Yu Han, Traditional Chinese Medicine (TCM) Specialist, General Secretary of the UK Association of Traditional Chinese Medicines (UK, China) Dr Yu Han is a doctor of traditional Chinese medicines in the United Kingdom. She studied traditional Chinese medicine and western medicines at the University of Beijing and the Academy of Chinese Medicines where she graduated in 1987. Following her studies, Dr Yu Han worked as a physician, then as an associate chief physician at the Acupuncture Institute of Academy of Chinese Medicine and WHO Traditional Medicine Training Centre. Since 1995, she has been working at the Chinese Healthcare Centre in London as a TCM practitioner and as the General Secretary of the UK Association of Traditional Chinese Medicines. Dr Yu Han is also the author of many articles and journals of TCM and Acupuncture. Dr Gramminger Harsha, Medical Practitioner, Ayurveda Practitioner, President of the European Ayurveda Association (Germany) Dr Gramminger is a medical practitioner specialised in ayurvedic medicine. She graduated from the University of Hamburg in 1986. Following her studies, she was a research assistant in a liver transplant team, first in Hamburg and then in Chicago. She received her Ayurveda training in India and the US. Since 1991, she has fully integrated the Ayurveda medicine into her practice. Between 1991 and 1999 she provided medical assistance and Ayurveda treatments in Italy. During this period, she undertook additional training on psychotherapy and terminal care. Dr Gramminger also has experience in ayurvedic yoga and massage therapies. Currently, Dr Gramminger is the President of the European Ayurveda Association and the Director of panchakarma treatments within the Ayurveda house. She is responsible for the education conducted at the Euroved academy. Dr Andreas Buchinger, Fasting Specialist, Chief Physician of the Clinic of Dr. Otto Buchinger (Germany) Dr Buchinger is an internal medicine specialist, having graduated as a Medical Doctor from the Leopold-Franzens-University of Innsbruck. He is also a trained naturopath, a nutritional mandated physician, an emergency physician, and provides basic psychotherapeutic services. Since 1988, Dr Buchinger is the chief physician of the Clinic of Dr. Otto Buchinger in Bad Pyrmont, which was founded by his grandfather in 1935. The Clinic of Dr. Otto Buchinger is the parent house of Buchinger Therapeutic Fasting, run by the third medical generation of the Buchinger family. Dr Buchinger is a member of various professional associations, such as the Hanover Association Medical Society Fasting and Nutrition, the International Society of Classical Natural Medicine and the Physician Chamber of Lower Saxony.

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Dr Buchinger is the author of many articles and books focusing on fasting and nutrition, such as ‘Remedial Fasting (1990)’, and ‘The remedial fasting after Buchinger’ (2000/2003). He is a visiting professor at the Medical Faculty of Hanover, the Medical Faculty of Baden-Baden and a lecturer in Austria, Greece, China, Russia and the USA. Dr Ton Nicolai, President of the European Committee for Homeopathy (Netherlands) Dr Ton Nicolai is the President of the European Committee for Homeopathy (ECH), the European association of medical doctors specialised in homeopathic medicine. He is a medical doctor, having graduated from Leiden University and practiced for over 10 years. Confronted with the limitations of conventional medicine, he studied several non-conventional therapies and eventually specialised in homeopathy. He has been running a homeopathic medical practice in Rotterdam for more than 25 years. Dr Nicolai is also a member of the International Homeopathic Medical League and the Netherlands Homeopathic Doctors’ Association. He is the author of many articles and co-author of books, such as ‘Homeopathy in Europe – Developing Standards for Professional Practice of Homeopathy in the European Union’ (1994), ‘A Strategy for Research in Homeopathy’(1997), ‘Towards a New Model of Health and Disease - A new perspective on how to achieve good health for all across the EU’ (2004), and ‘Complementary Medicine (CAM) - Its current position and its potential for European healthcare’ (2008). He has also contributed to the development of position papers of the ECH and CAMDOC Alliance. He was honoured as Companion of the Order of Orange-Nassau on behalf of the Queen of the Netherlands for his work for homeopathy in the Netherlands and abroad. He is Honorary Member of the International Homeopathic Medical League (LMHI), Honorary Fellow of the Faculty of Homeopathy in the United Kingdom, and he received the Globular Politics Award from the German Association of Homeopathic Physicians. Dr Natasha Campbell-McBride, Medical Doctor-Nutritional Consultant (UK, Russia) Dr. Campbell-McBride is specialised in using the nutritional approach as a treatment and has become recognised as one of the world’s leading experts in treating children and adults with learning disabilities and other mental disorders, as well as children and adults with digestive and immune disorders. She graduated as a medical doctor in 1984 from Bashkir Medical University in Russia. In the following years she gained a postgraduate degree in Neurology. After practising as a neurologist and then as a neurosurgeon in Russia, she moved to the UK. Her son’s autism prompted an intensive study into causes and treatments of the disease. It was during this time that Dr. Campbell-McBride developed her theories on the relationship between neurological disorders and nutrition, and completed a second Postgraduate Degree in human nutrition at Sheffield University, UK. Having treated her son off the autistic spectrum, Dr. Campbell-McBride returned to practice in 2000 and runs the Cambridge Nutrition Clinic. She is also the author of many books, such as ‘Gut and Psychology Syndrome’; and ‘Put You Heart In Your Mouth! What Really Is Heart Disease And What We Can Do To Prevent And Even Reverse It’.

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Policy Department A: Economic and Scientific Policy ____________________________________________________________________________________________ Dr Campbell-McBride is a keynote speaker at many professional conferences and seminars around the world. She is a member of The Society of Authors and a regular contributing health editor to a number of magazines and newsletters. Dr Aleksandar Mitov, Medical Doctor- Health specialist (Macedonia) Dr Mitov is a trained medical doctor, having graduated in 2006 from the Medical Faculty of Skopje. He has also attained a Master of Science Degree in Environmental Health from the Harvard Cyprus International Institute, and a Master in Philosophy in Environmental Policy from the University of Cambridge. The main focus of Dr Mitov’s research is on the systematic protection of health and the prevention of diseases. Dr. Mitov strongly advocates 'health in all policies', and supports the idea that a fundamental paradigm change is needed in the healthcare system in order to properly respond to the rise of chronic diseases combined with rising elderly population. He believes that this requires searching for modes of active prevention. Dr Elio Rossi, Medical Doctor/Director of a Homeopathy Clinic (Italy) Dr Rossi is a medical doctor and a homoeopathist specialised in using Complementary and Alternative Medicine (CAM) and therapies for treating cancer. He is also a director of a Homeopathy Clinic in Italy, called Campo di Marte Provincial Hospital of Lucca. Since 2009, Dr Rossi has been the scientific coordinator of an EU-funded research project, looking at the benefits of utilising CAM as a cancer care practice. Moreover, Dr Rossi is member of various professional associations, such as the Inter-regional Complementary Medicine Group of the Italian National Health Commission, the Regional Commission on Complementary Medicine Education and Training of Tuscany Region, and the European Information Centre of Complementary and Alternative Medicines. Between 2006-2009 he was also a member of the European Union Working Group 2 of COST Action E 39, dealing with allergies and CAM. Dr Rossi also has experience as a lecturer at the University of Bologna and Ravenna. His course touches upon the question of linking conventional and non-conventional therapies. Since 1998, Dr Rossi has been the scientific director of a journal on natural medicines. Dr Andrzej Rys, Director of the Health Systems and Products Directorate of DG SANCO Andrzej RYS is a medical doctor graduated from Jagiellonian University, Krakow, Poland. He specialized in radiology and public health. In 1991 he established the School of Public Health (SPH) at the Jagiellonian University and he was the SPH's director till 1997. From 1997-1999 he took up the post of director of Krakow's city health department. In 1995 -1999 he was the Polish director of the ‘Harvard-Jagiellonian Consortium for Health’ - a project focusing on local governments' role in health care. In 1999 - 2002 he became the deputy Minister of Health in Poland and developed a new system of emergency medicine and new education system for nurses. He was a member of the Polish accession negotiators team.

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In 2003 he established and ran as a director the Centre for Innovation and Technology Transfer at Jagiellonian University, Krakow, Poland. He was also director for development of Diagnostic Ltd., executive director of the Polish Association of Private Health Care Employers and chief editor of the Journal "Health and Management". He joined the European Commission in June 2006. He is currently the Director of the Health Systems and Products Directorate of DG SANCO.

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ANNEX III: PRESENTATIONS

1

Yu Han ( TCM Doctor)Chinese Healthcare Centre

London. [email protected]

2

1. What is TCM?

Traditional Chinese Medicine ( TCM ) has been developed in China and based on the tradition of more than 3000 years.

TCM is used by over 1/3 of population. It is used to preserve the well being of whole (body & mind) ,by curing and preventing disease.

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Historical Overview

TCM ( Traditional Chinese Medicine ) originated in China as early as ancient times.

*Food ‐‐‐‐ Herbal medicine; Dietary therapy *Fire ‐‐‐‐ Moxibustion; Hot compress; Cupping*Stone, Bone, Metal ‐‐‐‐ Acupoints; Acupuncture;

Meridians; Massage*Exercise ‐‐‐‐‐ Qi Gong

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* Xia. Shang. Zhou Dynasties period ( about 22 Century BC‐‐‐former 256 years )Archaeological digs have unearthed early types of acupuncture needles. Their oracular inscriptions onbones and tortoise shells refer to illness.

* < Huang Di Nei Jing > ( Yellow Emperior’s Inner Canon) formed in Qin dynasty ( 221—206 BC)is the earliest example of technical theory work .Specific works emerged on acupuncture and onherbal remedies. It’s the root of TCM system theory.Right to the twentieth century it was still used as a clear academic idea.

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•Ming dynasty(AD1368—1644) medicalexpert Li shi Zheng spent 27 years,completed TCM masterpiece compend‐ium of materia medica, encyclopediaof drug‐loading 1892, become thegreatest history of Chinese medicine.

*Qing Dynasty(AD 1644—1911) the doctors had rich experience to treat fever disease .

* Recent hundred years ,the combination of Chinese medicine and Western medicine has developed.

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* Yin and Yang is the key to the system Health: Yin and yang are balanced.

2.What Are The Ideas Behind TCM ?TCM has a strong philosophical background

Illness: Yin and Yang are out of balance

Treatment: To balance Yin and Yang

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*Five elements: They are basic materials in natural world, leads to a metamorphic view of the human body. “Integration of natural and human”( Tian Ren He Yi)

Wood.Fire EarthMetalWater

To explain the physiology and pathology.

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*Zang Fu: In TCM Zang Fu is the internal organs and physiological function.

*Integral whole : Liver, heart, spleen, lungs, kidneys as the core of the body, which link five systems, expand the concept of the body as an physiologically and pathologically.

*Wu Shen Zang: The emotions and Zang Fu affect each other. The balance is the harmony.

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*Meridians: Distributed all over the body, it acts as the important route for circulating Qi and blood , connecting and regulating the activities, connecting the tissues and organs to build up an organic integrity.

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* The Basic Substances of the Body

Qi ‐‐ Vital energy

Blood ‐‐ Nourishing the body

Body Fluids – Moisturing and nourishing the body

Jing ‐‐ Essence. Pre‐heaven: grows reproduction

Post‐heaven: development, promotes

Shen – Mind and spirit. Manifestation of consciousness.

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3.What are the major therapiesof TCM?

•Acupuncture

•Chinese Herbal Medicine

•Tui Na Massage

•Cupping Therapy

•Dietary Therapy

•Qi Gong

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Acupuncture• What can Acupuncture help?Acupuncture is used to treat a wide variety of conditions. The WHO recognised over 180 conditions that have been scientifically verified to respond well to the treatment.

• including: Musculoskeletal and rheumatologicalLower Back Pain, Arthritis, Frozen Shoulder, Tennis Elbow, Sciatica;

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Internal Medicine: asthma , bronchitis, gastritis, peptic ulcer, vomiting, constipation, IBS, diarrhoea, ulcerative colitis, gall stones/cholecystitis, headache, dizziness/ vertigo, epilepsy, insomnia, anxiety states, depression, chronic fatigue syndrome;

Gynaecology including menstrual irregularity, Menopause, dysmenorrhoea, premenstrual syndrome, endometriosis, morning sickness, female infertility;

Others: including Stroke (CVA), Bell's Palsy, Facial pain, Tinnitus, sinusitis & rhinitis; impotence, male infertility

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*Needles/Moxisbustion ‐‐ Acupoints ‐‐Meridians ‐‐ Qi and Blood can be regulated ‐‐balance Yin and Yang to treat disease.

*Mechanism of Acupuncture: Pain‐relieving effect –affect on endogenous opioids (endorphins and enkphalins ) – natural painkillers.

•Is Acupuncture safe?Generally speaking, acupuncture is very safe when carried out by a well‐qualified practitioner.Side‐effects of acupuncture: Pain, Bruise, Needle shockRare dangers: Infections, Aerothorax, Nerve damage, Death .

•How does Acupuncture work?

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Chinese Herbal Medicine There are about 130 ,000 kind of herbal medicines used in China, over 100,000 recipes recorded in the ancient literature.

Based upon natural plants(12807), very rarely minerals (89) and animalparts (158 ) (www.pharmnet.com.cn).

It’s comprehensive and flexible *Row Herbs. Plants (seeds, leaves, barks flowers, roots etc) *Formula Herbs : pills , capsules ,oral liquid, granules, powder ,intravenous fluid; and etc.

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*Who can be helped by Chinese Herbal Medicine?Patients of all age, even babies and pregnant women, unless someone is allergic to some herbs or is prohibited to use it for medical reasons.

*It’s safe to take Chinese Herbal Medicine?It’s safe when prescribed correctly by a properly

trained practitioner. Because: 1. complexity of plants materials is far more balanced than conventional drugs.2. less side‐effects3. Herbs are usually used in combination, the different components balance each other, which enhance safety.

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4.The Characteristic of TCM( 1 ) .The Overall Concept

As a whole: unity and integrity.

* The human body itself is an organic whole.

Between the structure of an integral functionally coordinated and mutually.

* The human body and nature are inseparable.

The whole concept of TCM reflects through the medical physiology diagnostic methods; differentiation and treatment aspects.

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( 2 ).Differential Treatment

This is the basic principle: understanding and treatment of disease.

How to make differentiation?

From four diagnostic methods ‐‐ Information ‐‐through analysis ‐‐ discern the cause ‐‐ the nature ‐‐location and relationship of the disease‐‐find the root of the imbalance ‐‐ select the right treatment.

such as clearing the heat /warming the coldness.

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5. TCM Development In China : A comprehensive TCM healthcare system now exists in China, TCM and Western medicine are equally important.

* In 2006, there were 3072 TCM hospitals with 333,000 beds; * Over 90% of general hospitals have a TCM department; * 524,000 licensed TCM Community clinics throughout China.

In UK : There is the largest number of TCM practitioners in Europe. About 2500 TCM practitioners, 4000 acupuncturists.

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NHS offers Acupuncture to back pain patientsBBC News, May 2009

Patients with persistent lower back pain should be offered acupuncture, massages or exercises by NHS, says NICE guidance.It is the first time the National Institute for Health and Clinical Excellence has explicitly backed the use of complementary therapies. Evidence suggests they help and will be cost effective .

Thank You

Organised by the Policy Department A-Economy & Sciencefor the Working Group on Health of the Committee on Environment, Public Health and Food Safety (ENVI)

Dr. med. Harsha Gramminger: Ayurveda

Workshop - "ALTERNATIVE MEDICINES"Wednesday, 30 November 2011European Parliament Brussels

1

Ayurveda - Background

• Ayurveda is a 5000 year old comprehensive system of medicine• It originates in the north of India • It is currently used by more than a quarter of the world’s

population• It is both: preventative and curative

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8 Branches

• Ayurveda has 8 branches, each of which deals with a particular aspect of the medicine system

Inner MedicineEar nose and throatSurgeryObstetrics and GynaecologyToxicologyPsychologyRejuvenation and GeriatricsReproductive Health

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Ayurveda - Therapeutics

• Ayurveda makes use of a number of different therapeutics such as

Diet and lifestyle adviceMedicines, oil massageHeat treatmentsDetoxification therapy called Pancha KarmaYoga and Meditation

... Just to mention a few...!

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Ayurveda is Scientific

• Ayurveda is not “quackery “ – it works on a scientifically measurable physiological and psychological level

• It helps to restore balance to the organism’s disharmony which is expressed in terms of Vata, Pitta and Kapha

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Individual Assessment

• Ayurveda treatment is prescribed on an individual basis • It normally requires a long consultation process to arrive at

the primary cause of the disease before reaching a diagnosis and treatment plan

• It is not a -One Hat Fits All - system

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Example

• Approach for a patient suffering from hyperacidity or reflux oesophagitis

Ayurveda looks for the cause of the acidity be it dietary, lifestyle, psychological, physiological, iatrogenic (primary or secondary), or occupationalIt gives dietary and lifestyle advice to neutralise the primary cause of acidity Together with medicines that restore the correct pH, improve the digestion and heal and support the tissues

... This is the holistic approach that is required for a full cure and this approach is applied to all Ayurvedic patients...

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Ayurveda is good for:

• Ayurveda works particularly well for chronic diseases such as

BurnoutDiabetesHypertensionHypercholesterolemia

• GIT conditions such as

Malabsorbtion syndrome

• Muscular skeletal, rheumatic and neurological conditions that can only at best be palliated using western medicines

... At the same time it works extremely effectively together with western medicine by reducing drug dosages, reducing secondary symptoms and reducing side effects...

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Good for the Patients…

• The good news is:

Patients, who would otherwise be long term drug dependent requiring complex medical interventions have the possibility of reducing or removing dependency by using Ayurvedic treatment!

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… Good for the MS (member states)!The Impact is that there would be huge financial and social benefits for the MS Healthcare Systems!

Prevention

• Ayurveda’s comprehensive system seeks to prevent disease and maintain the health of healthy people

• In terms of the

“EU initiative to improve the healthy years of the aged”

...Ayurveda can play a major role in achieving the two year target simply by giving suitable dietary and lifestyle advice...

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Start Young

• It is a sensible system to teach in primary and secondary schools to prepare adults to become fully responsible for their own health

• As we know many diseases can be avoided given the correct education on diet and lifestyle with support by the EU and MS Health services

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Patients‘ Freedom

• Treatments are currently available and patients try to inform themselves

• But: Insurance companies and governmental bodies are not confident enough to include Ayurveda or most of the other alternative medical systems in their scope of choice

• Funding for further research is required which would demonstrate its benefits and quantify the advantages

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Missing

• Missing are the Centres for information and the necessary financing from the State and Insurance companies

Alternative systems of medicine require long consultations and patients need to be able to afford these and their medicines andtreatments

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Who Pays?

• Currently only Allopathic medicine is financed by the State or Insurance companies

• This means, that all Ayurvedic consultations and treatments have to be paid by the patients

• A circumstance which reduces patient choice in an era where freedom to chose has been widely promoted

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People Driven

• Furthermore there is an increasing interest throughout the population to maintain the body and mental fitness by living a more balanced and healthy lifestyle

• This is thus requiring health education for the public includinginstruction in suitable sports, yoga and meditation

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Needs

• We need to have more Doctors trained and practicing Ayurvedic Medicine with Diet and Lifestyle advisors paid by the insurance companies and integrated into National Health Policy

... This will help to reduce and avoid disease and transfer valuable resources to more needy situations...!

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Ayurveda

• We are ready to help to reduce the burden on healthcare budgets!

• Please call us for further information!

... THANK YOU VERY MUCH FOR YOUR KIND ATTENTION!

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Contact Details:Dr. med. Harsha Gramminger

c/o Euroved, In den Forstwiesen 27, 56745 Bell, GermanyFon: 0049 2652 52 77 56Fax: 0049 2652 52 77 63

Email: [email protected]

Dr. med. Harsha Gramminger

CEO of Euroved

President EUAA (European Ayurveda Association)

Vice President of ANME (Association of Natural Medicine in Europe)

Medical Practitioner, Teacher and Author

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HOMEOPATHYWorkshop ‘Alternative Medicines’European Parliament30 November 2011

Dr Ton Nicolai, President European Committee for Homeopathywww.homeopathyeurope.org

Use of homeopathy

• “Over the past 30-40 years homeopathy has benefited from growing demand both from doctors and from the public in the majority of European countries. Three out of four EU citizens know about homeopathy of these 29% use it for their healthcare.”[Commission report to the European Parliament and Council on the application of Directives 92/73 and 92/74 - COM (97) 362 final]

• In other words: over 100 million European citizens use homeopathy for their healthcare.

• Total sales of homeopathic medicines in Europe € 900 million, i.e. 0.7% of the pharmaceutical market. 80% of total EU sales in France, Germany, Italy and Spain.

Reasons for citizens to choose homeopathy

• Homeopathy being a gentle, safe and effective therapy;

• Conventional treatment not being effective for their illness;

• Avoiding a long-term, or even life-long, dependency on conventional prescription drugs;

• Looking for a more personal approach;

• Increased sense of personal responsibility for health and healthcare;

• Easy access to internet to find other solutions for health problems.

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Homeopathic practice and training

• 50,000 physicians in Europe have taken training and education in homeopathy, around 3,500 non-medically qualified practitioners.

• Hospitals in Austria, France, Germany, Italy, Spain and the United Kingdom provide homeopathic treatment by physicians in their out-patient departments.

• At a number of European universities: familiarisation courses about homeopathy in the medical undergraduate curriculum and postgraduate training courses in homeopathy for physicians.

FRANCE

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Homeopathic practitioners

Predominantly MDs

Predominantly non-MDs

About equal numbers

Reasons for practitioners to choose homeopathy

• Homeopathy can be highly effective;

• Preference for using safe treatments over more risky conventional methods;

• Abiding by Hippocrates' principle: First, do not harm;

• Homeopathy if possible, conventional medicine if necessary.

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Principles of homeopathyEuropean traditional system of medicine based on the following principles:

•Similarity Principle: substances capable of causing disorder in healthy subjects are used

as medicines to treat similar patterns of disorder experienced by ill people.

•Health viewed as a dynamic process tending to maintain a state of optimum equilibrium.

Homeopathy aimed to direct and stimulate the organism’s self-regulatory mechanisms.

•Treatment highly individualised and based on holistic assessment. Characteristics of

chosen medicine to be as similar as possible to characteristics of illness in the patient.

Wide range of medicines necessary.

•Minute doses of substances of botanical, chemical, mineral, or zoological origin,

prepared in accordance with official pharmacopoeias.

Homeopathy as an effective treatment

• “In conclusion we have established that there is sufficient supporting evidence for the pre-clinical (experimental) as well as clinical effects of homeopathy, and that in absolute terms, as well as when compared to conventional therapies, it offers a safe and cost-effective treatment.”

[Bornhöft G, Matthiessen PF (2011) "Homeopathy in Healthcare: Effectiveness, Appropriateness, Safety, Costs" - Health Technology Assessment (HTA) report]

Cost savings by CAM practice

Annual costs (in CHF) at the expense of the compulsory health insurance of qualified CAM physicians and conventional physicians.

Source: Studer HP, Busato A. Ist ärztliche Komplementärmedizin wirtschaftlich? Schweizerische Ärztezeitung, 5 May 2010.

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700'000

600'000

500'000

400'000

300'000

200'000

100'000

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Conventional physician Qualified CAM physician

CHF 748'700

CHF 531'600

Cost savings by CAM practice

Average costs per patient for each CAM modality / savings potential (2008)

100%

80%

60%

40%

20%

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Source: santésuisse data pool 2008

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12 20 20

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Statutory regulation of CAM

• Wide variation among EU Member States: • government-administered regulations or laws on CAM practice

• regulation of specific CAM therapies

• government-sanctioned voluntary register of CAM practitioners

• no CAM regulation at all.

• Some Member States: diplomas of – dual-trained – CAM physicians issued and recognised by national medical associations.

• No mutual recognition of qualifications between the EU Member States, which impedes the free movement of CAM health professionals – MDs and non-MDs.

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National regulation of homeopathy

recognised as a therapeutic system by government (law)

authorisation by national medical association (MDs)

government-sanctioned voluntary CAM register

CAM qualifications for physicians

• Council Directive 2005/36/EC: mutual recognition of conventionalmedical qualifications, but not additional qualifications in anyparticular CAM modality.

• Our wish: Extending the scope of medical qualifications to include particular CAM modalities – and other qualifications without a full medical specialist status, including sports medicine, occupational medicine, preventive and social medicine –, and mutual recognition of CAM qualifications of physicians among the EU Member States to ensure the free movement of CAM services.

• The Commission intends to present a proposal revising Directive 2005/36/EC by the end of 2011.

CAM qualification for non-MDs• “The establishment of a regulatory regime for non-medically qualified

practitioners of holistic, long-standing traditions of medicine falls within the competence of individual Member States. Such nationalregulation must respect the principles of non-discrimination and proportionality. Member States are also free to decide whether public health considerations such as patients' safety should apply.”

• “Currently, the principle of mutual recognition established in Directive 2005/36/EC applies to the recognition of professional qualifications of non-medically qualified practitioners moving from one Member State to another. The host Member State issues a decision on the recognition of the qualifications of the practitioner within a period of four months.”

[Answer given by Mr Michel Barnier, Commissioner for Internal Market and Services to Parliamentary question E-007123/2011]

Legislation on homeopathic medicines

• 1992: Council Directive 92/72 specifically covering homeopathic medicines aiming at standardizing regulations, leading eventually to their free circulation.

Objective: “patients should be allowed access to the medicinal products of their choice”

• 2001: homeopathic medicines included in general pharmaceutical Council Directive 2001/83/EC.

• 2004: revision: Council Directive 2004/27/EC.

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National regulation of homeopathic medicinal products (HMP)

by law

Decreasing availability of HMP

• Disproportionally strict and cumbersome registration requirements

• Slow progress of the registration process in most of the Member States

• Inefficient mutual recognition procedure for simplified registration products

• Impossible harmonisation of homeopathic medicinal products with indications.

• Hardly any internal market as envisaged by the EC Treaty.

A separate legal framework?

• “[….] the set of requirements for the simplified registration procedure under Directive 2004/24/EC is not appropriate for a global regulation of such medical practices [anthroposophic, Ayurvedic and traditional Chinese medicine]. The regulation of such traditions would demand a different approach from that introduced by Directive 2004/24/EC.”

• “[….] the suitability of a separate legal framework for products of certain traditions should be assessed.”

[Commission Communication 2008 on the experience acquired as a result of the application of the provisions of Directive 2001/83/EC, as amended by Directive 2004/24/EC, on specific provisions applicable to traditional herbal medicinal products]

• As the Commission needs a request from the Parliament before it will take action, an initiative from the Parliament isneeded.

EUROCAM

• Multi-stakeholder group of physicians, practitioners and patients in the field of Complementary and Alternative Medicine (CAM).

• In EUROCAM the following associations collaborate:• ECH - European Committee for Homeopathy

• ECPM- European Council of Doctors for Plurality in Medicine

• ICMART - International Council of Medical Acupuncture and Related Techniques

• IVAA - International Federation of Anthroposophic Medical Associations

[These 4 associations constitute the CAMDOC Alliance, representing 132 national associations of dual-trained CAM physicians across Europe]

• EFCAM - European Federation for Complementary and Alternative Medicine,representing non-medically qualified practitioners in the field of CAM.

• EFHPA - European Federation of Homeopathic Patients' Associations

• EFPAM - European Federation of Patients' Associations for Anthroposophic Medicine

EUROCAM’s activities

• Meetings at DG SANCO – Director-General Ms Testori Coggi and previously Mr Madelin

• Close cooperation with the European Parliament CAM Interest Group, organising meetings about topics related to CAM. Next meeting, jointly with MEPs Against Cancer, on CAM care in cancer patients.

• With support by DG SANCO, organising a full-day conference about the added value of CAM for Public Health on 19 June 2012.

The Remedial Fasting After The Remedial Fasting After Dr. Otto Buchinger IDr. Otto Buchinger I

Andreas BuchingerAndreas Buchingerwww.buchinger.dewww.buchinger.de

Bad PyrmontBad Pyrmont

IntroductionIntroductionDr. Otto Buchinger I (born in 1878, 1966) fell severely ill 1917 with rheumatoid arthritis. In 1919 he cured himself by his first fasting. He established the ‘Klinik Dr. Otto Buchinger’ in 1920.Since 1920, many people fasted in the Clinic Dr. Otto Buchinger in Bad Pyrmont.For most of the Fasting clients ‘The Remedial Fasting' is a determining experience: physiologically advantageous and/or beneficial effects and lifestyle changes lead to sustainable improvements in the overall health status (and finally to cost savings).

Dr. Otto Buchinger II (born 1913, 2003) continued in Bad Pyrmont after WW II very successfully. He spread the message throughout Europe and Middle East, USA!

2Klinik Dr. Buchinger Bad Pyrmont 22‐11‐11

DefinitionDefinition

• Fasting – according to both Drs. Otto Buchinger I and II – is the conscious, voluntary renunciation of solid food for a limited period of time

• Fasting means nothing to chew, but to drink

• Fasting is multidimensional: it involves the physical, mental and spiritual dimension of fasters.

• The demand for energy is met from body reserves ‐ proven to protect vital structures of the body

• Fasting is a multidisciplinary approach that combines medicinal, physical therapy and exercise therapy with health education concepts (physical activities / nutrition)

• The Remedial Fasting is not a ‘zero‐calorie‐diet 'and not a ‘crash diet', but a low‐calorie drinking diet (between 250 ‐ 500kcal/day are administered)


Methodology: ComponentsMethodology: Components

• Plenty of liquids (mineral waters, various teas, vegetable broths, fruit‐ and vegetable juices), honey – max. 500kcal/day; occasionally additional buttermilk / yogurt, etc.

• Promotion of all elimination processes (intestines, kidneys, lungs, skin)

• Adequate balance between physical activities (sport as a very important component) and resting

• Careful re‐introduction of healthy food and introduction of a healthier lifestyle (by health education)

• Prevention and therapy (e.g. metabolic syndrome, type‐2‐diabetes NIDDM)

Literature: ‘Fasting Guidelines’ (Forsch Komplementärmed Naturheilk 2002;9: 189‐198); O Buchinger: ‘Das Heilfasten’, Hippokrates, 2005;


Various Kinds Of FastingVarious Kinds Of FastingVarious forms of Fasting•Therapeutic fasting (= Fasting Therapy, or Remedial Fasting)•Preventative fastingWith patient care•Stationary and medically directed attention and care for in‐patients: specialized clinics•Medically managed fasting for out‐patients: practicing physiciansThere is also a so‐called fasting for people in good health condition, as fasting here means only for (healthy) participants, good health condition proven by doctors


Related Fasting MethodsRelated Fasting Methods

• F. X. Mayr therapy: Fasting consists of 3 levels of an ‚intestinal refurbishment‘: 1st level tea‐water‐fasting, 2nd level milk‐bread diet, 3rd level light diet

• Schroth‐method: consisting of a carbohydrate pointed restrictive vegetarian diet, stimuli of ‚dry days‘alternating with small and large drinking days, and various elimination procedures such as ‚mist‐ or moist‐packs‘. Alcohol is sometimes used as a remedy.

• ‚Whey‐cure‘ and other variants: ‚whey‐cure‘ = protein‐modified fasting using natural whey; ‘mucus fasting’(whole grain oat flakes or buckwheat); more seldom tea‐ or water fasting


Indications Indications (selected)(selected)

• Metabolic diseases: e.g. metabolic syndrome, type‐2‐diabetes (NIDDM), visceral obesity, lipid disorders

• Cardiovascular system: e.g. high blood pressure, cardio‐vascular risk factors; disorders of the cardio‐vascular system

• Joints, soft parts: Rheumatoid arthritis; degenerative diseases of the musculoskeletal system, back pains, fibromyalgia

• Chronic inflammatory bowel diseases, functional gastrointestinal disorders, fatty liver, other liver diseases

• Eczema / nettle rash / acne / psoriasis• migraine• Allergies: e.g. pollen allergies, food allergies• Mood swings (positive mood‐effect)


ContraindicationsContraindications (selected)(selected)

• Type‐1‐diabetes (IDDM)

• Severe heart diseases (e.g. heart failure NYHA > III)

• Advanced liver‐ and renal failures

• Dementia

• Cancers (research under way)

• Psychoses

• Anorexia / bulimia

• Pregnancy / breast feeding


Metabolic Changes Within FastingMetabolic Changes Within Fasting

• Reduction in insulin production (insulin resistance ↓; results of insulin‐overproduction ↓

• Immobilization of the gastrointestinal tract, antigen‐pause, reduction of inflammatory processes

• The energy is delivered up to 95% from triglycerides, up to 5% from protein stores. This leads to the production of ketone bodies, which are (for example) used in turn to produce energy.

• Others (in the focus of research): reduction of IGF‐1 levels; Increased expression of Sirtuins; enormous anti‐inflammatory and anti‐aging effects


Medications To Be ObservedMedications To Be Observed

• Anti‐hypertensive medications• Diabetes medications• Systemic corticosteroids• Psychotropic drugs (neuroleptics, lithium) / anti‐epileptic medications

• Anticoagulants• NSAIDs (non‐steroidal drugs)Additional med’s: more often magnesium‐potassium‐supplementation.

Deficiencies re vitamins in or by Fasting are not proofed. Supplements might be administered in longer fasting periods or in detected deficiencies.

After fasting very often medications have to be reduced (cost saving effect). In insulin‐dependent type‐2‐diabetes a decreased insulin dosage may be expected or even a discontinuation of insulin.


Methodology: Preliminary ExaminationsMethodology: Preliminary Examinations

The following investigations are obligatory at the beginning of each fasting:•Structured medicinal history•Whole‐body status •Blood tests: complete blood cell counts, blood chemistry (e.g., minerals, liver and kidney function, uric acid), urine, TSHbasal / T3 / T4, possibly hsCRP and others•Blood pressure (BP), pulse•Electrocardiogram; possibly exercise test•Additional investigations (in case of suspicious symptoms): 24‐hrs. blood pressure monitoring, abdominal sonogram, vascular duplex sonogram, sleep‐apnea‐screening, etc.


PossiblePossible Phenomena In FastingPhenomena In Fasting

• Headaches (e.g. tension headache, caffeine withdrawal h.); possibly migraines; others

• Lumbago (lower back pains)

• Muscle cramps

• Sleep disorders

• Low blood pressure

• Intense dreamsNot very often presented!

• Mood upswings (more often)


Termination CriteriaTermination Criteria

• Non‐Compliance• Therapy‐refractory gastrointestinal complaints (e.g. suspected gastric ulcer)

• Cardiac arrhythmias of highest grade • Severe disorders of electrolyte balance (esp. sodium, potassium)

• Severe blood pressure regulation disorders of at least 2 days

In practice, hardly ever seen!


General MethodologyGeneral Methodology

• Preparation days (‘transition days’) consisting of vegetables and then of fruit meals, should be performed 2 days before fasting starts

• Renunciation from stimulants • Regular, daily physical activities (should become a habit)

• Mental and emotional adjustments: removal of relaxation hindering bad habits, less daily stresses, more time for rest and exercise. ‘Inner experiences’ (nature, music, literature, meditation)


Methodology: Daily FastingMethodology: Daily Fasting‐‐BeveragesBeverages

Fluid intake (~ 2.5‐3 liters / day) has high priority!

•Fruit juices, sometimes diluted with mineral water; 0.25‐0.5 liters max.

•Vegetable broths: 0.25‐0.5 liters max.

•Tea’s, plus organic honey max. 2‐3 tsp distributed over the day

•Mineral waters (preferably no gas)


Methodology: LaxativesMethodology: Laxatives

• On the first day of Fasting once 30‐40gs sodium sulphate (NaSO4) is administered, dissolved in 0.5‐0.75 liters of water, to be sipped within 20 minutes (taste correction by an organic juice)

• Alternatives: passage salt, Epsom salt

Reasons: the empty intestinal tract prevents the feeling of discomfort, but this also reduces the unwanted sensation of appetite (as some might call that wrongly ‘hunger’); from that point on the faster feels ‘clean’ from inside!


Methodology: Bowel Cleansing Methodology: Bowel Cleansing Procedures Within The CourseProcedures Within The Course

Necessary because of a decreased intestinal motility during fasting, because of continued bile secretion, as well as continued exfoliation of gastric and intestinal mucosa cells, and because of dead intestinal bacteria (otherwise, toxin exposure happens in non‐elimination)!

•Every second day bowel enemas (lukewarm water), or alternatively passage salt (MgSO4), or cabbage juice (depending also on personal preferences)


Methodology: ReMethodology: Re‐‐Alimentation Alimentation (Post Fasting Days)(Post Fasting Days)

• ,Break of Fast': stepwise re‐introduction of solid food components to be chewed very well: 2 apples very well chewed morning & midday, in the evening a consistent potato‐vegetable soup

• 1st – 4th building‐up day: on the basis of easily digestible, low‐calorie, ovo‐lacto‐vegetarian, ‘whole foods' (foods from organic production)

• Target: prescribed calories (individually adjusted) to also introduce improved nutritional preferences (learning by self‐experience)


Outcomes (Positive Effects)Outcomes (Positive Effects)• Previously elevated lipids decrease significantly (both triglycerides

and cholesterol)• Blood sugar levels drop (because of a sustainable drop of insulin

levels) – which also decreases the insulin resistance considerably (beneficial e.g. in metabolic syndrome and type‐2‐diabetes)

• Liver enzymes decrease (by e.g. the elimination of intracellular fat)• Blood pressure decreases and normalizes• The waist circumference decreases significantly; distinct weight

losses • The mobility increases significantly• Increase of the sense of life and joy of life• The overall positive outcomes are sustainable!• The sum of the positive results through fasting are long lasting!Due to the included health education in the Remedial Fasting (in terms

of exercise and nutrition) the participant (health insurances also) has –as a result – sincere sustainability of the successes plus cost savings!


Research On Fasting Research On Fasting (excerpts) (excerpts)

• R Weindruch, Wisconsin Primate Research Center, Madison / USA: Fasting or caloric restriction, fasting and caloric restriction positive against ageing

• G Dobos, Department of Naturopathy and Integrative Medicine of the Clinics Essen‐Mitte (GER): e.g. Glycotoxines & calorie restriction, fasting, life‐extension by fasting, delay age‐related diseases. Nearly ubiquitous effects!

• R Strange, OA Immanuel‐Hospital Berlin; A Michalsen, Department of Natural Medicine, Immanuel Hospital, Charité Campus Benjamin Franklin, Berlin‐Wannsee, Berlin: e.g. fasting against metabolic syndrome; Fit byrenunciation

• Valter D Longo, Univ. of Southern California / USA: e.g. Fasting as an adjunct to treatment for cancer

• S Spindler, University of California at Riverside, "PNAS", Volume 101, Page 5524/2004: Fasting slows chronic inflammatory processes and proliferation of malignant cells down (Life Extension)

Research on the (positive) effects are ongoing! Fasting is still (and even more) subject to studies and research!


NUTRITIONAL THERAPY

FOR BRAIN PROBLEMS

Dr Natasha Campbell-McBride MD

All diseases begin in the gut!Hippocrates, 460-370 BC

The primary seat of insanity generally is in the region of the stomach and

intestinesPhillipe Pinel, 1807

Modern clinical experience confirms the connection between the state of the gut

and the health of the brain

Food comes in Food is split into nutrientsby good bacteria

Bacteria keep the intestine wall clean

Vitamins released

Roles of Gut Flora

Reduced/Absent Populations of Normal Flora

Candida Species Overgrowth

Clostridia Species

Sulphate Reducing Bacteria

Viruses: Measles, Herpes, CMV, etc

Patients with brain dysfunction suffer from gut dysbiosis

Gut Dysbiosis - The Unhealthy Gut

Bad bacteria attack the lining

Parasites thrive

Food cannot be absorbed

Moulds give off toxins

Child Adult

• AUTISM

• ADHD/ADD

• DYSLEXIA

• DYSPRAXIA

• LEARNING, BEHAVIOURAL, SOCIAL PROBLEMS

• EPILEPSY

• SUBSTANCE ABUSE

• DEPRESSION

• EATING DISORDERS

• OBSESSIVE-

COMPULSIVE

• MANIC-DEPRESSIVE

• SCHIZOPHRENIA

• EPILEPSY

The treatment has to focus on the

gut health!

Appropriate Diet is the most important

treatment!

Nutritional supplements, natural

detoxification & life-style changes

Nutritional Protocol

www.Doctor-Natasha.com

www.GAPS.me

Dr. Aleksandar Mitov MSc MPhil

Does mainstream medicine need a paradigm change?

Current paradigm: reaction.

2.8% of total health expenditure dedicated on prevention programmes

(EU average)

Source: OECD Health Data 2010; Eurostat Statistics Database.

By 2050 the number of people in the EU aged 65+ will grow by 70%. The 80+

age group will grow by 170%

Eurostat population projections published on the International Day of Older Persons 29 September 2006.

Healthcare costs for cardiovascular disease – 12% of total health

expenditure * (around 75% all chronic diseases)

* Source: Petersen et al. (2005).

An alternative is needed, one that will focus on prevention.

Criteria

1. Scientific

2. Measurable

3. Cost effective

PoH Thermoregulation Method

is based on:

proper nutrition, AMP Analyzer, and use of natural oils

1. Scientific

“Phytotherapy” in published articles

Source: US National Institute of Health

Plant – based Diet

The CHINA Study

"produced more than 8000 statistically significant associations between various

dietary factors and disease.”

T. Colin Campbell PhD

“Diabetes is curable” 2006

“Reversal of type 2 diabetes: normalisation of beta cell function in association with decreased pancreas and liver triacylglycerol”, Taylor et al.

2011

Natural cold pressed oils,

in doses given by nature itself, easily absorptive and familiar to our bodies, help the body to gradually establish

balance and heal itself.

Vis Medicatrix Naturae

Grape seed oil / extract (GSE)

“Inhibits human breast carcinoma MCF-7, human lung cancer A-427 and human gastric cancer CRL-1739 cell growth.”

“Inhibits growth, induces cell-cycle arrest and causes apoptotic death of human breast carcinoma MDA-MB468 and prostate carcinoma DU145 and LNCaP cells in culture.”

“GSE exerts anti-inflammatory, anti-bacterial, anti-viral, anti-nociceptive, and other health beneficial effects in human disease conditions such as atherosclerosis, hyperglycemia, etc .”

2. Measurable

AMP Non-invasive Analyzer

A method developed basing on kinematic laws of mass transfer and functioning

of receptor and mediator, and on molecular kinetic exponential

relationship between response rate and temperature and transformation of temperature into radiation energy.

The principle of operation of the AMP noninvasive analyzer is based on

processing of behavior of temperature indicators in representation points

(bifurcation of the carotid artery: on the left and on the right, in axillary and

abdominal areas).

Brief prophylactic medical examination without considerable expenses and

non-invasive.

3. Cost effective

Prevention

is by far more cost effective than intervention.

Source: BMJ Clinical evidencehttp://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp

Thank you!

Policy Department A‐Economy & ScienceCommittee on the Environment, Public Health and Food Safety (ENVI)

Working Group on Health

Workshop"ALTERNATIVE MEDICINES"

Wednesday, 30 November 2011European Parliament, BrusselsRoom Altiero Spinelli, A5‐G‐2

Complementary and Alternative Medicine in cancer

Elio RossiTuscany Region Network for Integrative Medicine (Italy)

CAM use in cancer treatment• Many cancer patients use complementary and alternative therapies (CAM) in addition

to conventional treatment, which may have implications for the clinical management of these patients. They need correct information.

• Herbal medicines and supplements were the most commonly used CAM therapies, together with homeopathy, vitamins/minerals, anthroposophic medicine, Chinese traditional medicine, spiritual therapies and relaxation techniques.

• The motivation to seek help from alternative treatment is not based on a distrust of conventional care.Maintaining hope and taking an active role in self‐care are the main stimuli for using alternative medicine.

CAM cancer treatment vs conventional• Most pediatric cancer patients, regardless of their ethnic origin, use CAM without

informing their physicians.

• Some breast cancer patients opt for alternative treatments in place of conventional treatments.

• Alternative therapies used as primary treatment for breast cancer can be associated with increased recurrence and death. Homeopathy, if used instead of surgery, resulted in disease progression in most patients. (Chang et al. 2006).

CAM prevalence in adult patients with cancer

• Systematic review (26 surveys/n=3649)– CAM use ranges from 7‐64%, while average prevalence is 31.4% (Ernst

& Cassileth 1998)• US study (n=453)

– 83.3% had used at least one approach.– 62.6% used vitamins/herbs (62.6%), 59.2% movement and physical

therapies (Richardson et al. 2000)• Europe study (n= 956)

– 35.9% uptake (least one form of CAM) (Molassiotis et al. 2005)

CAM prevalence in children with cancer

• Surveys of families of children with cancer indicate that CAM is used worldwide:– with 31% to 46% use in the Netherlands, Finland, Australia, and Canada,

and higher use (73%) in Taiwan (Post White & Hawkes 2005)• UK study (n=49)

– 32.7% reported using some type of CAM– most commonly used therapies included multivitamins, aromatherapy

massage, diets and music as therapy(Molassiotis & Cubbin 2004)

Reviews and studies about CAM in cancer treatment

(or Integrative oncology)

Evidence‐Based Clinical Practice Guidelines for IntegrativeOncology

Botanical supplements are among the most common CAM approaches used by cancer patients. A 2008 review of the research literature concluded that some botanicals used in Ayurvedic medicineand traditional Chinese medicine may have a role in cancer treatment. However, scientific evidence is limited—much of the research on botanicals and cancer treatment is in the early stages. The review also notes that botanicals can have side effects and can interact with cancer drugs, blood thinners and other prescription drugs, and each other.

Conclusions (EUSOMA 2004)

The views expressed in this paper are those of the authors themselves, as it proved extremely difficult for allmembers of the workshop to reach a consensus on the currentstate of affairs, …. But one thing we all accept is that practitioners of conventional medicine and of CAM are working in good faith to improve the length and QoL for women with breast cancer. The way forward is to build bridges between the cultures based on the guidelines…We choose to describe this as a consensual rather than an integrative approach.

Anthroposophic treatment Viscum album, very diffused among cancer patients in North Europe

To date, relatively little is known about the safety and effectiveness of complementary and alternative medicine (CAM) therapies that people may use for cancer. However, some CAM therapies have undergone careful evaluation, and many more studies are being carried out every year.

In 2009, the Society for Integrative Oncology issued evidence‐based clinical practice guidelines for doctors to consider when incorporating complementary therapies in the care of cancer patients.

National Center for Complementary and Alternative Medicine (NCCAM)

Key Points in CAM cancer treatment of the Society for Integrative Oncology

• CAM therapies should never be used as a replacement for conventional cancer care or as a reason to postpone seeing a doctor about any problem.

• There is limited scientific evidence suggesting that some CAM approaches may be useful in managing some symptoms of cancer and side effects of treatment. At present, there is no convincing evidence regarding CAM use in preventing or curing cancer.

• Before using any CAM therapy, people who have been diagnosed with cancer should talk with the doctors who treat their condition—to make sure that all aspects of their cancer care work together. Be aware that some dietary supplements can interfere with standard cancer treatments.

• Cancer patients need to make informed decisions about using CAM. The National Center for Complementary and Alternative Medicine (NCCAM) and the National Cancer Institute have written a brochure that can help: Thinking About Complementary and Alternative Medicine: A Guide for People with Cancer www.cancer.gov/cancertopics/thinking‐about‐CAM

• In evaluating CAM therapies, people should be wary of extreme claims. Remember: if it sounds too good to be true—for example, claims that a CAM therapy can cure cancer—it usually is.

Integrative oncology: the Tuscany model

Levels of Evidence of acupuncture in oncologySymptoms

or organs

Studies Guidelines

USA

Guidelines

GB

Levels of

Evidence

PNLG*

Strenght of recommendat.

PNLG*

Notes

Nausea and

vomiting

post‐chemio

therapy

5 Review, 7

RCT

and trials

1 B Nausea e

vomiting not

responding

I B

Oncologic

pain

5 Review,

4 RCT

and trials

1 A Pain not

controlled by

conventional

analgesic

treatment

I

B

Strong

raccomandati

on PNLG

in pain not

controlled by

conbventional

treatment

Xerostomy 4 Review,

3 RCT

and trials

1 B Xerostomy II A

* Programma nazionale per le linee guida (PNLG)

Levels of Evidence of phytotherapy in oncology

Medicinal

Plant

Possibile

indications

Studies Levels of

Evidence

PNLG*

Strenght of recommend.

PNLG*

Cautions Notes

Green Tea

Chemiopreven

tion

Sistem.

Reviews and

meta‐analysis

III A

Reduces

efficacy of

bortezomib

Green Tea

Intraepitelial

prostatic

carcinoma

1 RCT

II A

Reduces

efficacy of

bortezomib

Hipericum

Light and

medium

depression

Many RCT,

sistem.

reviews and

meta‐analysis

I A Multiple

Interactions

Dry Estract

registered

drug

Cannabis ind. Vomit post

chemio‐

therapy

Sistem.

reviews and

meta‐analysis

I A Adverse

Effects

Medico legal

problems

Liquorice Prevention of

HCC in

hepatitis HCV

Observational

Studies

+ RCT

I B

Possible hypo

K and/or

hypertension

art.

Possible use in

mucositis


Levels of Evidence of homeopathic therapies in oncologyDrug Therapeutic

indicationsStudies Levels of

Evidence

PNLG*

Strenght of recommendat.

PNLG*

Cautions Notes

Calendula cream Prevention and treatment of

induced by radio therapy dermatitis

1 RCT II B

Traumeel S (TRS. NewYork NY:USA)

Stomatitis induced by chemiotherapy

1 RCT II B

Viscum albumCa colon rectumCa pancreas

and other types of tumors

Many RCT sistematic review and meta-analysis

I B Hyperthermia after the treatment

SCDS (estracts di Embryo Zebrafish )

Glioblastoma,hepatocarcinoma,

ovaric, lung, colon rectum tumours

Observational

studies only in cases of advanced stage without conventional treatment or with palliative

II B Non responders to the conventional treatment only


Interactions between herbal drugs and anticancer treatments

• Green tea reduces the efficacy of bortezomib, used for treatment of mieloma (Golden EB, et al. Blood 2009)

• Phytoestrogens (which are present in Soia, Cimicifuga rac., etc.) interact with tamoxifenreducing its efficacy (Firenzuoli, Gazz. Med. Ital. 2003).

• Hypericum reduces the efficacy of irinotecan (Borrelli, et al. AAPS J. 2009)

• Aloe vera reduces the activity of cisplatin (Mijatovic S, et al. Cell Mol Life Sci. 2005 )

• Potential interaction resulting in liver toxicity of imatinib and Panax ginseng ( Bilgi N et al. Ann Pharmacother 2010)

Different experiencies of integrative oncology in Europe : centres, courses, universitary

masters, congresses.

Merano (Bz)ItalyLocarno

Swizerland

Tucany RegionItaly

KohlnGermany

EssenGermanyLondon

UK

StrasburgFrance

Stokolm

Rome Italy

Humlebaek Denmark

WienAustria

ArlesheimSwizerland

Integrative oncology centres in Europe: first draft of a map

Bad MergentheimGermany

, Budapest Hungary

Killaloe Ireland

LisbonPortugal

Malaga, Spain

Milan Italy

Bruxelles 2006 Milano 2009

Integrative Care for the Future is an international organization devoted to the support, study and dissemination of evidence‐based, complementary therapies that are used to control symptoms associated with cancer and other serious illnesses. (www.IntegrativeCareftFuture.org)

The First International Conference on Integrative Care for the Future was held in The Netherlands on March 11 and 12 2011.

Integrative medicine faces challenges as it attempts to develop a larger presence. The First International Conference addressed the economic, political, regulatory, educational and professional health care landscape in a diverse group of nations. It was chaired by Barrie Cassileth, PhD, Chief of the Integrative Medicine Service at Memorial Sloan‐Kettering Cancer Center, New York

• “CAM‐Cancer” is the name of a project entitled "Concerted Action for Complementary and Alternative Medicine Assessment in the Cancer Field" (CAM‐Cancer). Originally funded by the European Commission (EC) within the Framework 5 Programme, it is now hosted by the National Information Center for Complementary and Alternative Medicine (NIFAB) at the University of Tromsø, Norway.

The aims of the CAM‐Cancer project were: • to prepare and disseminate suitable evidence‐based

information for health professionals in order to assist them in informing their patients;

• to build an international authoritative network around CAM in cancer with a panel of experts in CAM research and/or in cancer care with privileged contacts with cancer organizations.

European Partnership

for Action Against Cancer (EPAAC)

http://www.epaac.eu/

• The European Partnership for Action Against Cancer (EPAAC) was launched in 2009, after the European Commission published its Communication on Action Against Cancer: European Partnership.

• The specificity of the Partnership is that it brings together the efforts of different stakeholders into a joint response to prevent and control cancer. In its initial phase, until early 2014, the work of the Partnership will be taken forward through a Joint Action (cofinanced by the EU Health Programme). The National Institute of Public Health in Slovenia has assumed the role of leader of the EPAAC Joint Action, which encompasses 38 associated partners from across Europe and over 90 collaborating partners.

EPAACEuropean Partnership Action Against Cancer

Associated partners involved in WP7

•National Coordination for Oncological Diseases, High Commissariat of Health, Ministry of Health, Portugal, NCCOD

•Polish Ministry of Health, PMH

•Catalan Institute of Oncology, ICO •French National Cancer Institute, INCa•European Health Management Association, EHMA

•European Society for Paediatric Oncology, SIOPE European Hospital and Healthcare Federation, HOPE

•European Society for Clinical Nutrition and Metabolism, ESPEN

•European Oncology Nursing Society, EONS •Norwegian Directorate of Health. Norwegian University of Science and Technology, NTNU

•European School of Oncology, ESO •Regione Toscana, Italy RTI•Belgium Ministry of Health BMH

Work package 7 Health CareSpecific objective of WP7 :

To identify and assess best practices across European health services, promoting the exchange of experiences focusing on innovative organizational approaches, including patient’s perspective.

Specific objective(s) of Tuscany Region•To assess evidence and use of Complementary and Alternative Medicine (CAM) in cancer care and to propose criteria for dissemination of appropriate information.•Assessment of dissemination of CAM, review of the evidence (workshop) and mapping of the EU CAM in cancer care (survey). •Survey to Cancer Units of Hospitals across EU to identify clinical activities related to integrative medicine. A map of the activities will be defined (M20). Workshop reviewing the evidence of the literature via Medline with the CAM therapies (herbal medicine, anthroposophy, homeopathy and acupuncture) will be reviewed. Also, interactions with chemotherapy will be analyzed. SIGN criteria will be used in grading literature. •Experts form different EU centres (n=30) with published experience and representatives of scientific societies involved in cancer care will be invited to the final workshop in order to discuss the report. •The final deliverable will be: Use of CAM in cancer care, with evidence reviewed.

5th European Congress for Integrative Medicine (ECIM) 2012 in Florence ‐ Italy

_________________________________________________________________________

21st ‐ 22nd September 2012 5th European Congress for Integrative Medicine (ECIM) Palazzo dei congressi ‐ Florence (Italy).

20 September: Opening Cerimony at Palazzo Vecchio

Promoted by

Tuscany Region – Health General Direction

University Charité Berlin

http://www.ecim-congress.org

Conclusion

Integrative/Complementary Medicine can be a bridge between Patients and Doctors.It could be the balance point where Cureis complemented by Care and Ambitionmitigated by Empathy.

Volker Diehl. MDUniversity of Cologne,

Germany

Thank you for your attention !

directorate general for internal policies - european parliament

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